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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01478594
Registration number
NCT01478594
Ethics application status
Date submitted
21/11/2011
Date registered
23/11/2011
Date last updated
8/07/2015
Titles & IDs
Public title
A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy
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Scientific title
A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects
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Secondary ID [1]
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2011-003502-24
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Secondary ID [2]
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4130-CL-0201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tivozanib
Treatment: Drugs - Bevacizumab
Treatment: Drugs - mFOLFOX6
Experimental: Tivozanib + mFOLFOX6 - Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
Active Comparator: Bevacizumab + mFOLFOX6 - Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
Treatment: Drugs: Tivozanib
Capsules for oral administration
Treatment: Drugs: Bevacizumab
Solution for intravenous infusion
Treatment: Drugs: mFOLFOX6
mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, leucovorin calcium 400 mg/m^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, fluorouracil 400 mg/m^2 administered as an intravenous bolus over 5 to 15 minutes on Days 1 and 15, then 2400 mg/m^2 continuous intravenous infusion over 46 hours on Days 1 to 3 and 15 to 17.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Investigator-assessed Progression-Free Survival (PFS)
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Assessment method [1]
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The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1):
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.
Participants who did not progress or had not died at the time of the analysis were censored at the date of last tumor assessment where non-progression was documented.
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Timepoint [1]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [1]
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Progression-Free Survival (PFS) Based on Independent Radiological Review (IRR)
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Assessment method [1]
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The time from the date of randomization until the date of radiological disease progression assessed by the IRR or until death due to any cause, even in the absence of radiological progression.
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival (OS) is defined as the time from the date of randomization until the documented date of death. Participants still alive at the time of analysis were censored on the last day the participant was known to be alive.
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Timepoint [2]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) confirmed a minimum of four weeks apart based on RECIST 1.1 criteria.
CR: Disappearance of all target and non-target lesions and no new lesions.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and no progression of non-target lesions and no new lesions, or, disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.
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Timepoint [3]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [4]
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Duration of Response (DoR)
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Assessment method [4]
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Duration of response (DoR) is defined as the time from the date of the first documented response of CR or PR (whichever is first recorded) to documented progression or death. If a participant did not progress or had not died at the time of analysis, the duration of response was censored at the date of last tumor assessment. Duration of response is only defined for participants whose best overall response was CR or PR.
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Timepoint [4]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [5]
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Time to Treatment Failure (TTF)
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Assessment method [5]
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Time to Treatment Failure (TTF) is defined as the time from randomization to last dose date of tivozanib/bevacizumab. If a participant discontinued treatment for any reason, the participant was considered as an event. Participants remaining on treatment at the time of analysis were censored at date of last dose.
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Timepoint [5]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [6]
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Health Related Quality of Life (HRQoL)
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Assessment method [6]
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Time to deterioration in HRQoL measured by Colorectal cancer (CRC) subscale of the Functional Assessment of cancer Therapy Colorectal (FACT-C) scale, change in score from baseline using the European Quality of Life - 5 Dimensions (EQ-5D) and Fact Colorectal Symptom Index (FCSI) were not evaluated due to study closure.
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Timepoint [6]
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3 years
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Secondary outcome [7]
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Safety as Assessed by Physical Examination, Vital Signs, Laboratory Assessments, 12-lead Electrocardiogram (ECGs), and Adverse Events (AEs)
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Assessment method [7]
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An abnormality identified during a medical test is defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion.
An AE was serious if it resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required or prolonged inpatient hospitalization or other medically important event.
AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute Common Terminology Criteria for Grading Adverse Events (NCI-CTCAE) Version 4.03 per the following: 1=mild; 2= moderate; 3= severe; 4= life threatening; 5=death.
Treatment-related AEs were defined as events where the relationship to study drug was marked as probably or possibly, or was missing.
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Timepoint [7]
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From first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib (tiv) arm and 162.0 days in the bevacizumab (bev) arm.
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Secondary outcome [8]
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Progression-free Survival Events by Lactate Dehydrogenase (LDH) Level
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Assessment method [8]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum lactate dehydrogenase status.
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Timepoint [8]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [9]
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Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-A (VEGF-A) Level
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Assessment method [9]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum vascular endothelial growth factor-A (VEGF-A) level. VEGF-A protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.
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Timepoint [9]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [10]
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Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-C (VEGF-C) Level
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Assessment method [10]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C level. VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.
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Timepoint [10]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [11]
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Progression-free Survival Events by Serum VEGF-C / VEGF-A Ratio
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Assessment method [11]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C/VEGF-A ratio. VEGF-A and VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the ratio is expressed relative to the observed median.
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Timepoint [11]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [12]
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Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-2 (sVEGFR-2) Level
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Assessment method [12]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-2 level. sVEGFR-2 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.
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Timepoint [12]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [13]
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Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-3 (sVEGFR-3) Level
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Assessment method [13]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-3 level. sVEGFR-3 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.
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Timepoint [13]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [14]
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Progression-Free Survival Events by Serum Interleukin-8 (IL-8) Level
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Assessment method [14]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum interleukin-8 level. IL-8 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.
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Timepoint [14]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [15]
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Progression-Free Survival Events by Serum Neuropilin Level
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Assessment method [15]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum neuropilin level. Neuropilin protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.
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Timepoint [15]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [16]
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Progression-Free Survival Events by Tumor VEGF-A Ribonucleic Acid (RNA) Level
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Assessment method [16]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-A RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.
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Timepoint [16]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [17]
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Progression-Free Survival Events by Tumor VEGF-C RNA Level
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Assessment method [17]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.
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Timepoint [17]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [18]
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Progression-Free Survival Events by Tumor VEGF-C / VEGF-A RNA Ratio
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Assessment method [18]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C/VEGF-A RNA ratio.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.
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Timepoint [18]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [19]
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Progression-Free Survival Events by Tumor VEGF-D RNA Level
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Assessment method [19]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-D RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.
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Timepoint [19]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Secondary outcome [20]
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Progression-Free Survival Events by Tumor Placental Growth Factor (PIGF) RNA Level
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Assessment method [20]
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The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor PIGF RNA level.
RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level.
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Timepoint [20]
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From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.
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Eligibility
Key inclusion criteria
- Documented diagnosis of metastatic colorectal cancer
- One measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- No prior systemic chemotherapy for advanced colorectal cancer; no fluorouracil
containing adjuvant therapy in previous 6 months
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any prior Vascular Endothelial Growth Factor (VEGF)-directed therapy or any other
agent or investigational agent targeting the VEGF pathway
- Primary Central Nervous System (CNS) malignancies or CNS metastases
- Hematologic abnormalities:
- Hemoglobin < 9.0 g/dL,
- Absolute neutrophil count (ANC) < 2000 per mm^3,
- Platelet count < 100,000 per mm^3,
- Prothrombin (PT) or Partial Thromboplastin Time (PTT) > 1.5 X Upper Limit of
Normal (ULN)
- Serum chemistry abnormalities:
- Total bilirubin > 1.5 X ULN,
- Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) > 2.5 X ULN,
- Alkaline phosphatase > 2.5 X ULN,
- Serum albumin < 2.0 g/dL,
- Creatinine > 1.5 X ULN,
- Proteinuria > 2+ by urine dipstick
- Significant cardiovascular disease
- Significant thromboembolic or vascular disorders within 6 months prior to
administration of first dose of study drug
- Non-healing wound, bone fracture, or skin ulcer
- Inadequate recovery from any prior surgical procedure or major surgical procedure
within 8 weeks prior to administration, or anticipation of major surgical procedure
during the course of the study
- History of significant gastrointestinal (GI) toxicity, diarrhea, or stomatitis within
the last 6 weeks
- An active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or
other gastrointestinal condition with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within 4 weeks prior to administration of first dose of study drug
- Serious/active infection or infection requiring antibiotics
- Significant bleeding disorders within 6 months prior to administration of first dose
of study drug
- Active second primary malignancy, other than non-melanoma skin cancers, non-metastatic
prostate cancer, in situ cervical cancer and ductal or lobular carcinoma in situ of
the breast. Subject is not considered to have a currently active malignancy if they
have completed anti-cancer therapy and have been disease free for > 5 years
- History of allergic reactions, or intolerance, attributed to compounds of similar
chemical or biologic composition to 5-fluorouracil, history of Grade 3
hypersensitivity to oxaliplatin, history of allergic reaction to folic acid
- Female subject is pregnant or lactating
- Known history of genetic or acquired immune suppression disease including Human
Immunodeficiency Virus (HIV); subjects on immune suppressive therapy for organ
transplant
- Inability to swallow pills, malabsorption syndrome or gastrointestinal disease, major
resection of the stomach or small bowel, or gastric bypass
- Uncontrolled neuro-psychiatric disorder or altered mental status
- Peripheral neuropathy = Grade 2
- Participating in another interventional protocol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2015
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Sample size
Target
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Accrual to date
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Final
265
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
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Recruitment hospital [1]
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St George Hospital - Kogarah
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Recruitment hospital [2]
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Tweed Hospital - Tweed Heads
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Recruitment hospital [3]
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0
Calvary Mater Newcastle - Waratah
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Recruitment hospital [4]
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0
Flinders Medical Centre - Bedford Park
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Recruitment hospital [5]
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0
Royal Hobart Hospital - Hobart
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Recruitment hospital [6]
0
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Ballarat Health Services - Ballarat
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Recruitment hospital [7]
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0
Cabrini Hospital Malvern - Malvern
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Recruitment hospital [8]
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0
Border Medical Oncology - Wodonga
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Recruitment postcode(s) [1]
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0
2217 - Kogarah
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Recruitment postcode(s) [2]
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0
2485 - Tweed Heads
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Recruitment postcode(s) [3]
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0
2298 - Waratah
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Recruitment postcode(s) [4]
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0
5042 - Bedford Park
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Recruitment postcode(s) [5]
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0
7000 - Hobart
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Recruitment postcode(s) [6]
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3350 - Ballarat
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Recruitment postcode(s) [7]
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3144 - Malvern
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Recruitment postcode(s) [8]
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3690 - Wodonga
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Arizona
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0
0
United States of America
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State/province [2]
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0
California
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0
0
United States of America
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State/province [3]
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0
Colorado
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0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Hawaii
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0
0
United States of America
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State/province [6]
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0
Illinois
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0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
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0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
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0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New York
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Country [11]
0
0
United States of America
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State/province [11]
0
0
North Carolina
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Ohio
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Oklahoma
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Oregon
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Pennsylvania
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Country [16]
0
0
United States of America
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State/province [16]
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0
Utah
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0
0
United States of America
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State/province [17]
0
0
Washington
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Country [18]
0
0
Austria
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State/province [18]
0
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Graz
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Country [19]
0
0
Austria
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State/province [19]
0
0
Salzburg
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0
0
Austria
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State/province [20]
0
0
Wels
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Country [21]
0
0
Belgium
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State/province [21]
0
0
Antwerpen
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Country [22]
0
0
Belgium
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State/province [22]
0
0
Bonheiden
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0
0
Belgium
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State/province [23]
0
0
Brugge
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0
0
Belgium
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State/province [24]
0
0
Kortrijk
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Country [25]
0
0
Canada
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State/province [25]
0
0
British Columbia
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Country [26]
0
0
Canada
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State/province [26]
0
0
Nova Scotia
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Country [27]
0
0
Canada
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State/province [27]
0
0
Quebec
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Country [28]
0
0
Czech Republic
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State/province [28]
0
0
Brno
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Country [29]
0
0
Czech Republic
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State/province [29]
0
0
Hradec Kralove
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Country [30]
0
0
Finland
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State/province [30]
0
0
Tampere
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Country [31]
0
0
Finland
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State/province [31]
0
0
Turku
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Country [32]
0
0
Hungary
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State/province [32]
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0
Budapest
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Country [33]
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0
Hungary
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State/province [33]
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Gyor
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Country [34]
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Hungary
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State/province [34]
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Gyula
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Country [35]
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Hungary
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Szekesfehervar
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Country [36]
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Italy
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Bologna
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Italy
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Candiolo
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Country [38]
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Italy
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State/province [38]
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Genova
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Country [39]
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Italy
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State/province [39]
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Rozzano (MI)
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Country [40]
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Netherlands
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Breda
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Country [41]
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Spain
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Aragon
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Country [42]
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Spain
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Cantabria
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Country [43]
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Spain
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Cataluna
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Country [44]
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Spain
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Galicia
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Country [45]
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Spain
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Madrid
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Country [46]
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United Kingdom
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State/province [46]
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Cambridge
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Country [47]
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United Kingdom
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State/province [47]
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Edinburgh
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Country [48]
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United Kingdom
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State/province [48]
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Glasgow
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Country [49]
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United Kingdom
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London
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Country [50]
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United Kingdom
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State/province [50]
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Maidstone
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Country [51]
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United Kingdom
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State/province [51]
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Manchester
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Country [52]
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United Kingdom
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State/province [52]
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Peterborough
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AVEO Pharmaceuticals, Inc.
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Address
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Ethics approval
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Summary
Brief summary
The objective of this study is to compare the progression free survival (PFS), overall
survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of
response (DoR), quality of life, safety and tolerability of tivozanib in combination with
mFOLFOX6 and bevacizumab in combination with mFOLFOX6.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01478594
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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AVEO Pharmaceuticals, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01478594
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