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A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 (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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02836028
Pfizer
Withdrawn
A Study Evaluating Talazoparib in Relapsed Ovarian, Fallopian Tube, and Peritoneal Cancer

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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 SummaryThe 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 DescriptionNot 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 DateJune 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Myriad Genetic Laboratories, Inc.
  • Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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