Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
NCT01286987
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
Adult Trials: 18+ Years
- Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor
- Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
- 18 years of age or older.
- Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Have adequate organ function
- Able to take oral medications.
- Willing and able to provide informed consent.
- Sexually active patients must be willing to use an acceptable method of contraception.
- Females of childbearing potential must have a negative serum pregnancy test at screening.
- Willing and able to comply with all study procedures.
Part 2 Dose Expansion Tumor Types:
- Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.
- Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease.
- Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC.
- Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease.
- Part 2 Expansion: Prior treatment with a PARP inhibitor.
- Has history of central nervous system (CNS) metastasis.
* Exception: In patients with SCLC, history of adequately treated brain metastasis who
do not require corticosteroids for management of CNS symptoms.
- Has had major surgery within 28 days before Cycle 1, Day 1.
- Has active peptic ulcer disease.
- Active gastrointestinal tract disease with malabsorption syndrome.
- Pregnant or breastfeeding at screening or planning to become pregnant (in each case,
either oneself or one's partner) at any time during the study.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors | ||||||
| Official Title ICMJE | A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors | ||||||
| Brief Summary | This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
| ||||||
| Intervention ICMJE | Drug: Talazoparib
Oral capsule with multiple dosage forms given once daily Other Names:
| ||||||
| Study Arms ICMJE | Experimental: Talazoparib
Intervention: Drug: Talazoparib | ||||||
| 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 | Completed | ||||||
| Actual Enrollment ICMJE | 113 | ||||||
| Original Estimated Enrollment ICMJE | 70 | ||||||
| Actual Study Completion Date ICMJE | January 30, 2017 | ||||||
| Actual Primary Completion Date | March 31, 2015 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Part 2 Dose Expansion Tumor Types:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| 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 | United Kingdom, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01286987 | ||||||
| Other Study ID Numbers ICMJE | PRP-001 2010-023062-40 ( EudraCT Number ) C3441007 ( Other Identifier: Alias Study Number ) | ||||||
| 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 | Medivation, Inc. | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | June 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||