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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00862134
Registration number
NCT00862134
Ethics application status
Date submitted
12/03/2009
Date registered
16/03/2009
Date last updated
10/01/2013
Titles & IDs
Public title
Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
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Secondary ID [1]
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PR104-2003
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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:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PR104
Treatment: Drugs - docetaxel
Treatment: Drugs - docetaxel
Treatment: Drugs - Granulocyte colony-stimulating factor
Active comparator: Docetaxel 75 mg/m^2 - Subjects randomized to the docetaxel arm will be administered 75 mg/m\^2, IV, every 21 days (an approved dose and schedule)
Experimental: PR104 + 60 mg/m^2 docetaxel - Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.
Treatment: Drugs: PR104
770 mg/m\^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
Treatment: Drugs: docetaxel
75 mg/m\^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
Treatment: Drugs: docetaxel
60 mg/m\^2, IV, every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
Treatment: Drugs: Granulocyte colony-stimulating factor
Subjects randomized to PR104/docetaxel will receive prophylactic G-CSF per package insert administration recommendations. Number of Cycles: until progression or unacceptable toxicity develops.
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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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Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone
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Assessment method [1]
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Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
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Timepoint [1]
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Participants were followed for the duration on study, an average of 4 months
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Secondary outcome [1]
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Safety and Tolerability: Serious Adverse Events
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Assessment method [1]
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The number of participants with at least one Serious Adverse Event was measured.
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Timepoint [1]
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30 days following last administration of study treatment
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Secondary outcome [2]
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Positive Aldo-keto Reductase 1C3 (AKR1C3) Expression in Participating Patients
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Assessment method [2]
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AKR1C3 was evaluated on a semi-quantitative scale, and the percentage of cells staining at each of the following four levels was recorded: 0 (unstained), 1+ (weak staining), 2+ (moderate staining) and 3+ (strong staining).
Patients with a strong staining score (3+) were considered to be AKR1C3 positive
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Timepoint [2]
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Within 1 year of enrollment
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Eligibility
Key inclusion criteria
* Subjects with locally advanced or metastatic NSCLC (stage IIIb/IV) who have relapsed following adjuvant or first line therapy with a platinum containing regimen, and are appropriate candidates for treatment with single agent docetaxel
* Confirmed NSCLC by prior pathological analysis (tissue aspirate or biopsy)
* At least 21 days from prior chemotherapy
* At least 30 days from prior irradiation therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy of 12 weeks or more
* Adequate hematologic function [Absolute neutrophil count (ANC) = 1.5 x 10^9/L; platelet count =100x10^9/L; hemoglobin =8.5 g /dL maintained in the absence of red blood cell transfusions; and prothrombin time international normalized ratio =1.7; or prothrombin time =2 seconds above control)
* Adequate hepatic function (albumin =2.8 g/dL; total bilirubin =2 mg/dL [51.3 µmol/L]; and alanine aminotransferase and aspartate aminotransferase =1.5 times the upper limit of the normal range)
* Adequate renal function (serum creatinine =2.0 times the upper limit of the normal range or creatinine clearance =60 mL/min).
* At least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
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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
* Previous treatment with docetaxel (prior treatment with paclitaxel permitted)
* Receipt of more than one prior systemic chemotherapy regimen
* Active concomitant malignancy likely to effect any of the primary or secondary outcome measures in the current study
* Women who are pregnant, breast-feeding or planning to become pregnant during the study
* Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose
* Evidence of a significant medical disorder or laboratory finding that, in the opinion of the Investigator, compromises the subject's safety during study participation
* Active Central Nervous System (CNS) metastatic disease requiring intervention
* Less than 4 weeks since major surgery
* Known human immunodeficiency virus (HIV) positivity
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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
Stopped early
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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
1/03/2009
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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
1/05/2010
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Sample size
Target
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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California
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Florida
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Michigan
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Nevada
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North Carolina
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Ohio
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State/province [14]
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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Texas
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Canada
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Quebec
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New Zealand
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State/province [19]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Proacta, Incorporated
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The current understanding of PR104 justifies the evaluation of PR104 with docetaxel in subjects with Non Small Cell Lung Cancer (NSCLC). These include: * Aldo-keto reductase 1C3 (AKR1C3). NSCLC has been shown to express high levels of AKR1C3 in about one half of tumors tested. Subjects with high levels of AKR1C3 should have increased activation of PR104 within their tumor. * Hypoxia. NSCLC has been demonstrated to be a tumor with hypoxia based on both direct tumor measurements (oxygen electrodes) and hypoxic positron emission tomography (PET) imaging. Tumor hypoxia in NSCLC should be sufficient to activate PR104 to its active metabolites PR104H and PR104M. * Preclinical data. The use of docetaxel and PR104 alone and in combination in preclinical models demonstrates activity of PR104 as a single agent and supraadditive activity when PR104 and docetaxel are used in combination. * Manageable toxicity. PR104 and docetaxel with Granulocyte Colony-stimulating Factor (G-CSF) have been combined in a prior phase I study. A Maximum Tolerated Dose (MTD) has been identified and the major toxicities of this combination are understood. The current study will provide an estimate of the activity of PR104 in subjects with NSCLC. This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity in NSCLC to warrant a larger phase III registration study in this indication. Primary objectives • Estimate the response rate (RR) of PR104/docetaxel Secondary objectives * Evaluate survival * Evaluate progression free survival (PFS) * Evaluate time to progression (TTP) * Evaluate safety * Evaluate the pharmacokinetics of PR104 and its metabolites * Evaluate the pharmacokinetics of docetaxel * Evaluate the tumor hypoxia using 18F-fluoromisonidazole (18F-MISO) PET imaging * Collect diagnostic biopsy samples for the determination of AKR1C3 * Collect plasma samples for assessment of potential biomarkers of tumor hypoxia
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Trial website
https://clinicaltrials.gov/study/NCT00862134
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00862134
Download to PDF