A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors
NCT03077607
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
1. Arm A: At least 18 years of age and <65 years of age (at the time point of consent) and willing and able to provide informed consent. Arm B: At least 18 years of age (at the time point of consent) and willing and able to provide informed consent.
2. Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative breast cancer) judged by the Investigator to not be appropriate for standard therapy.
3. ECOG performance status ≤ 2 at screening and at time of enrollment.
4. Expected life expectancy of ≥ 3 months.
5. Able to swallow the study drug and comply with study requirements.
6. Female subjects may be enrolled if they are considered not of childbearing potential, or who are post-menopausal, or are of childbearing potential using a highly effective form of contraceptive, and female subjects should not donate eggs from the time point of investigational medicinal product (IMP) administration until at least 45 days thereafter.
7. Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a woman of childbearing potential, and do not donate sperm from the time point of study drug administration until at least 105 days thereafter, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.
8. Female subjects must not be breastfeeding at screening and during the study participation until 45 days after the last dose of the study drug.
9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
1. Treatment within 14 days or 5 half lives prior to dosing with any type of systemic
anticancer therapy or any investigational agent, whichever is longer
2. Major surgery within 8 weeks before screening.
3. Serious accompanying disorder or impaired organ function.
4. Symptomatic or impending spinal cord compression or cauda equina syndrome.
5. Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture
caused by a pre-existent pathological bone lesion.
6. Known myelodysplastic syndrome.
7. Subjects with the following serologies should be excluded: HBsAg+ or anti-HBc+;HCV+;
HIV+.
8. Serious or unstable medical condition that interferes with ability to tolerate
treatment or assessments associated with the protocol.
9. Gastrointestinal disorder affecting absorption.
10. Known hypersensitivity to any of the talazoparib capsule components.
11. Any condition or reason that interferes with ability to participate in the study,
causes undue risk, or complicates the interpretation of safety data, in the opinion of
the Investigator or Sponsor (e.g. non-compliance, excessive alcohol consumption,
intake of drugs of abuse unless these drugs are medically indicated [e.g. opiates for
pain relief].
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Descriptive Information | |||||
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Brief Title ICMJE | A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | A PHASE 1 OPEN-LABEL, TWO-ARM,DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECT OF ITRACONAZOLE AND RIFAMPIN ON THE PHARMACOKINETICS OF TALAZOPARIB IN PATIENTS WITH ADVANCED SOLID TUMORS | ||||
Brief Summary | This is a study in patients with advanced solid tumors for the investigation of P-gp inhibition and induction on the PK of talazoparib. | ||||
Detailed Description | Subjects participating in this study with no clinically significant toxicities and no disease progression may be eligible to continue treatment on a separate extension protocol (MDV3800-13). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Advanced Solid Tumors | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Elmeliegy M, Láng I, Smolyarchuk EA, Chung CH, Plotka A, Shi H, Wang D. Evaluation of the effect of P-glycoprotein inhibition and induction on talazoparib disposition in patients with advanced solid tumours. Br J Clin Pharmacol. 2020 Apr;86(4):771-778. doi: 10.1111/bcp.14178. Epub 2020 Jan 7. | ||||
* 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 | 36 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | January 20, 2018 | ||||
Actual Primary Completion Date | December 19, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Hungary, Moldova, Republic of, Poland, Russian Federation | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03077607 | ||||
Other Study ID Numbers ICMJE | MDV3800-04 C3441004 ( Other Identifier: Alias Study Number ) 2016-001813-26 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Medivation, Inc. | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |