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Trial record 1 of 1 for:    NCT02836028
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A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT02836028
Recruitment Status : Withdrawn
First Posted : July 18, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
Myriad Genetic Laboratories, Inc.
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 18, 2016
Last Update Posted Date September 18, 2018
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
Determine Objective Response Rate (ORR) [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02836028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Progression-free survival (PFS) [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • PFS at 24 weeks [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • Gynecologic Cancer Intergroup (GCIG) CA125 response rate [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • Clinical benefit rate at 24 weeks [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • Duration of response (DOR) [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • Time to response [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • Overall survival [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, SAE, AE related to study drug, SAE related to study drug. [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  • Pharmacokinetics of talazoparib as assessed by trough plasma concentrations [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
Official Title  ICMJE A Phase 2, Multiple-Cohort, Open-Label, International Study of Talazoparib Monotherapy and Talazoparib Plus Temozolomide in Women With Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer
Brief Summary The purpose of this phase 2, multiple-cohort, randomized, open-label, international study of talazoparib (a poly (ADP-ribose) polymerase (PARP) inhibitor) is to compare the efficacy and safety of talazoparib monotherapy and talazoparib plus temozolomide in women with relapsed ovarian, fallopian tube, and peritoneal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Talazoparib
    Talazoparib monotherapy 1mg/day orally
    Other Names:
    • MDV3800
    • BMN673
  • Drug: Temozolomide
    temozolomide 37.5 mg/m2 on days 1-5 of each cycle
Study Arms  ICMJE
  • Experimental: talazoparib
    Cohorts 1A (PARP inhibitor naïve), 2A (PARP inhibitor sensitive), and 3A (PARP inhibitor refractory)
    Intervention: Drug: Talazoparib
  • Active Comparator: talazoparib + temozolomide
    Cohorts 1B (PARP inhibitor naïve), 2B (PARP inhibitor sensitive), and 3B (PARP inhibitor refractory)
    Interventions:
    • Drug: Talazoparib
    • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 20, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2016)
500
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women ≥ 18 years of age and willing and able to provide informed consent
  • Relapsed, histologically confirmed ovarian, fallopian tube, and peritoneal cancer. Histologic subtypes include serous, endometrioid, clear-cell, mixed, undifferentiated histology, and carcinosarcoma.
  • Sufficient archival tumor tissue available or consent to a fresh tissue biopsy for biomarker analysis. Consent to blood sample collection for biomarker analysis is required.
  • Disease progression per RECIST 1.1 during or after the last treatment. Have metastatic disease with at least 1 target tumor lesion measurable per RECIST 1.1 on the screening scan. Lesions used for biopsies cannot be designated as a measurable lesion for RECIST 1.1 assessments.
  • Additional criteria for cohort 1 include the following:
  • Have a deleterious germline or a somatic BRCA1 or BRCA2 mutation, or a high diagnostic HRD test score (myChoice score ≥ 42), which represents a loss of DNA repair function based on testing performed at a sponsor-approved laboratory
  • Received at least 1 and no more than 3 platinum-based chemotherapy regimens (prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization
  • No prior PARP inhibitor treatment (COHORT 1 ONLY)
  • Additional criteria for cohorts 2 and 3 include the following:
  • Received at least 2 platinum-based chemotherapy regimens (including first-line chemotherapy; prior bevacizumab is allowed) and the last dose is ≥ 28 days before randomization
  • Received prior PARP inhibitor treatment as a single agent or in combination therapy regimen and the last dose is ≥ 28 days before randomization, as follows:
  • For cohort 2 only: Received PARP inhibitor treatment for ≥ 6 months and had a response of CR, PR, or stable disease for ≥ 6 months
  • For cohort 3 only: Received PARP inhibitor treatment for < 6 months with no response (disease progression or stable disease)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Estimated life expectancy of ≥ 3 months.
  • Able to swallow drugs, have no known intolerance to study drugs or excipients, and able to comply with study requirements.

Exclusion Criteria:

  • Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
  • Use of any investigational agent within 14 days before randomization.
  • Had > 2 paracentesis procedures within 28 days before randomization.
  • Major surgery within 14 days before randomization.
  • Requirement for intravenous alimentation (at the time of randomization).
  • Diagnosis of MDS.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836028
Other Study ID Numbers  ICMJE MDV3800-11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Myriad Genetic Laboratories, Inc.
  • Medivation, Inc.
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP