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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Recruitment Status : Withdrawn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

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Talazoparib Drug: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2016
Estimated Primary Completion Date : June 2020


Arm Intervention/treatment
Experimental: talazoparib
Cohorts 1A (PARP inhibitor naïve), 2A (PARP inhibitor sensitive), and 3A (PARP inhibitor refractory)
Drug: Talazoparib
Talazoparib monotherapy 1mg/day orally
Other Names:
  • MDV3800
  • BMN673

Active Comparator: talazoparib + temozolomide
Cohorts 1B (PARP inhibitor naïve), 2B (PARP inhibitor sensitive), and 3B (PARP inhibitor refractory)
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




Primary Outcome Measures :
  1. Determine Objective Response Rate (ORR) [ Time Frame: Anticipated in about 44 months following first patient enrolled ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  2. PFS at 24 weeks [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  3. Gynecologic Cancer Intergroup (GCIG) CA125 response rate [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  4. Clinical benefit rate at 24 weeks [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  5. Duration of response (DOR) [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  6. Time to response [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  7. Overall survival [ Time Frame: Anticipated in about 44 months following first patient enrolled ]
  8. 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 ]
  9. Pharmacokinetics of talazoparib as assessed by trough plasma concentrations [ Time Frame: Anticipated in about 44 months following first patient enrolled ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836028


Sponsors and Collaborators
Pfizer
Myriad Genetic Laboratories, Inc.
Medivation, Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02836028     History of Changes
Other Study ID Numbers: MDV3800-11
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Temozolomide
Talazoparib
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors