Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
NCT01286987
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Scottsdale, Arizona
- Scottsdale, Arizona
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Los Angeles, California
- Santa Monica, California
- Santa Monica, California
- Bloomington, Indiana
- Indianapolis, Indiana
- Indianapolis, Indiana
- Indianapolis, Indiana
- Ann Arbor, Michigan
- Houston, Texas
- Sutton, Surrey
| 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 | |||||||