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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/NCT02659020
Registration number
NCT02659020
Ethics application status
Date submitted
15/01/2016
Date registered
20/01/2016
Date last updated
9/05/2022
Titles & IDs
Public title
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
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Scientific title
A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma
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Secondary ID [1]
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I5B-MC-JGDL
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Secondary ID [2]
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15839
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Universal Trial Number (UTN)
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Trial acronym
ANNOUNCE 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Soft Tissue Sarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Olaratumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo
Experimental: Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel - Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Experimental: Phase 1b: Cohort 2 overall - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel - Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Experimental: Phase 2: Olaratumab + Gemcitabine + Docetaxel - Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Placebo Comparator: Phase 2: Placebo + Gemcitabine + Docetaxel - Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Treatment: Drugs: Olaratumab
Administered IV
Treatment: Drugs: Gemcitabine
Administered IV
Treatment: Drugs: Docetaxel
Administered IV
Treatment: Drugs: Placebo
Administered IV
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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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Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
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Assessment method [1]
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A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0:
Febrile neutropenia with documented Grade =3 infection or sepsis
Grade 4 neutropenia lasting 7 days or longer.
Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage.
Nonhematologic Grade =3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea that can be controlled with optimal medical management within 48 hours.
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Timepoint [1]
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Cycle 1 (Up To 21 Days)
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Primary outcome [2]
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Phase 2: Overall Survival (OS) (Olaratumab-Naive)
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Assessment method [2]
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OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
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Timepoint [2]
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Baseline to Date of Death Due to Any Cause (Up To 38 Months)
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Secondary outcome [1]
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Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab
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Assessment method [1]
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Cmax of Olaratumab.
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Timepoint [1]
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Pre-dose, 5 minutes (min), 1, 4, 4.5, 24, 96, 168, 336 hours (h) post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8
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Secondary outcome [2]
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Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab
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Assessment method [2]
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Cmin of Olaratumab.
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Timepoint [2]
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Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1
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Secondary outcome [3]
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Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab
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Assessment method [3]
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T1/2 of Olaratumab.
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Timepoint [3]
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Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8
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Secondary outcome [4]
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Phase 1b/2: PK: Cmax of Gemcitabine
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Assessment method [4]
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Cmax of Gemcitabine.
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Timepoint [4]
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Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion)
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Secondary outcome [5]
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Phase 1b/2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-8]) of Gemcitabine
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Assessment method [5]
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AUC[0-8] of Gemcitabine
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Timepoint [5]
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Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion)
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Secondary outcome [6]
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Phase 1b/2: PK: Cmax of Docetaxel
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Assessment method [6]
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Cmax of Docetaxel.
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Timepoint [6]
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5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8
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Secondary outcome [7]
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Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-8]) of Docetaxel
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Assessment method [7]
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AUC [0-8] of Docetaxel.
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Timepoint [7]
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5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8
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Secondary outcome [8]
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Phase 1b/2: Population PK: Clearance of Olaratumab
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Assessment method [8]
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Population PK: Clearance of Olaratumab
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Timepoint [8]
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Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8
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Secondary outcome [9]
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Phase 1b/2: Population PK: Volume of Distribution at Steady State (Vss) of Olaratumab
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Assessment method [9]
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The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2).
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Timepoint [9]
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Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8
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Secondary outcome [10]
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Phase 2: Overall Survival (Olaratumab Pre-Treated)
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Assessment method [10]
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OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
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Timepoint [10]
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Baseline to Date of Death Due to Any Cause (Up To 38 Months)
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Secondary outcome [11]
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Phase 2: Progression Free Survival (PFS)
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Assessment method [11]
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PFS was defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.
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Timepoint [11]
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Baseline to Objective Disease Progression or Death from Any Cause (Up To 38 Months)
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Secondary outcome [12]
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Phase 2: Percentage of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
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Assessment method [12]
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ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
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Timepoint [12]
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Baseline to Objective Disease Progression or Start of New Anti-Cancer Therapy (Up To 38 Months)
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Secondary outcome [13]
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Phase 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)
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Assessment method [13]
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DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [13]
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Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up To 38 Months)
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Secondary outcome [14]
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Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
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Assessment method [14]
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The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (=) 2 points from baseline or an analgesic drug class increase of =1 level. If the patient has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
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Timepoint [14]
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Baseline to Follow-up (Up To 24 Months)
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Secondary outcome [15]
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Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
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Assessment method [15]
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The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
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Timepoint [15]
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Baseline to Follow-up (Up to 33 months)
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Secondary outcome [16]
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Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
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Assessment method [16]
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The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
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Timepoint [16]
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Cycle 1 (Day 1), Follow-up (Up to 38 Months)
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Secondary outcome [17]
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Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
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Assessment method [17]
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Number of Participants with Treatment Emergent Anti-Olaratumab Antibodies
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Timepoint [17]
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Baseline through Follow-Up (Up to 38 Months)
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Eligibility
Key inclusion criteria
- The participant may have no more than 2 prior lines of systemic therapies (neoadjuvant
and adjuvant therapies will not be considered as a prior line of therapy) for advanced
or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy.
All previous therapies must have completed = 3 weeks (21 days) prior to first dose of
study drug.
- In the Phase 2 part, prior olaratumab/doxorubicin combination therapy in 1 prior
treatment line is allowed.
- Prior olaratumab therapy must have been received with doxorubicin as indicated on
the olaratumab label.
- Prior olaratumab therapy must have included at least 2 full cycles of
olaratumab/doxorubicin (that is, a minimum of 4 doses of olaratumab).
- Participants, who completed at least 2 cycles of combination
olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or
maximum dosing and proceeded to olaratumab monotherapy, are eligible.
- The most recent dose of olaratumab must have been received within 180 days of
randomization in this study.
- Availability of tumor tissue is mandatory for study eligibility. The participant must
have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or be
subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future
central pathology review and translational research (if archived tissue is
unavailable).
- The participant has adequate hematologic, organ, and coagulation function within 2
weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2).
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Minimum age
16
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
- The participant is diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi
sarcoma.
- The participant has active central nervous system (CNS) or leptomeningeal metastasis
(brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2).
Participants with a history of a CNS metastasis previously treated with curative
intent (for example, stereotactic radiation or surgery) that have not progressed on
follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving
systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs
or symptoms of neurological compromise should have appropriate radiographic imaging
performed before enrollment (Phase 1b) /randomization (Phase 2) to rule out brain
metastasis.
- The participant has received prior treatment with gemcitabine or docetaxel. Note:
Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943) or any other blinded
study with olaratumab are not eligible to participate in this trial.
- The participant has electively planned or will require major surgery during the course
of the study.
- Females who are pregnant or breastfeeding.
- The participant has an active fungal, bacterial, and/or known viral infection
including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
(screening is not required).
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/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
1/03/2016
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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
27/04/2021
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Sample size
Target
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Accrual to date
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Final
310
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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United States of America
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State/province [6]
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Massachusetts
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United States of America
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State/province [7]
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Missouri
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Country [8]
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United States of America
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State/province [8]
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Nebraska
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Country [9]
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United States of America
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State/province [9]
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New York
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United States of America
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State/province [10]
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Ohio
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United States of America
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State/province [11]
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Oklahoma
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United States of America
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State/province [12]
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Pennsylvania
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0
United States of America
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Tennessee
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United States of America
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State/province [14]
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Texas
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United States of America
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Utah
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United States of America
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Washington
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United States of America
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Wisconsin
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France
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State/province [18]
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Bordeaux
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France
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State/province [19]
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Lille Cedex
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France
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State/province [20]
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Villejuif Cedex
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Germany
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State/province [21]
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Niedersachsen
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Germany
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Berlin
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Hungary
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Szolnok
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Israel
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Ramat Gan
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Israel
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Haifa
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Israel
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Petah Tiqva
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Israel
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Tel Aviv
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Italy
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Torino
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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United Kingdom
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Greater London
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United Kingdom
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Merseyside
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United Kingdom
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State/province [38]
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Scotland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer
drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in
participants with advanced soft tissue sarcoma (STS) or STS that has spread to another
part(s) of the body.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02659020
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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0
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02659020
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