An open label study to provide extended treatment in patients treated with Talazoparib.
- Conditions
- Advanced solid tumorsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001972-31-DE
- Lead Sponsor
- Pfizer, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Each patient eligible to participate in this study must meet all of the following criteria:
1.Treated with talazoparib as a single agent or in combination with another agent in a qualifying talazoparib clinical study in advanced solid tumors sponsored by Medivation/ Pfizer and has no ongoing National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 talazoparib related toxicities.
2.Willing and able to provide informed consent for extended open label treatment.
3.Eastern Cooperative Oncology Group (ECOG) performance status = 2.
4.Able to swallow capsules whole, have no known intolerance to talazoparib or excipients, and able to comply with study requirements throughout the study.
5.Able to tolerate = 0.25 mg/day talazoparib during the originating study.
6.Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through 7 months after the last dose.
7.Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of talazoparib through 4 months after the last dose. Contraception should be considered for a nonpregnant female partner of childbearing potential.
8.Female patients may not be breastfeeding at the first dose of talazoparib and must not breastfeed during study participation through 7 months after the last dose of talazoparib.
9.Male and female patients must agree not to donate sperm or eggs, respectively, from the first dose of talazoparib through 4 and 7 months, respectively, after the last dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78
1.Permanently discontinued from any Medivation/ Pfizer sponsored study with talazoparib alone or in combination with another agent.
2.Received an antineoplastic therapy or investigational agent after treatment with talazoparib in the originating study.
3.Has a clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or pulmonary disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator.
4.Diagnosis of myelodysplastic syndrome (MDS).
5.For patients entering from studies MDV3800 01 (renal impairment) or MDV3800 02 (hepatic impairment), clinically significant deterioration of renal or hepatic function, respectively, after dosing in the originating study.
6.Serious accompanying disorder or impaired organ function, including the following:
•Renal: Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by the MDRD equation (Modification of Diet in Renal Disease [available via www.mdrd.com]), except for patients from study MDV3800 01 (renal impairment) with severe renal impairment (eGFR 15 29 mL/min/1.73 m2).
•Hepatic:
–For patients entering from all other qualifying studies excluding MDV3800 02 (hepatic impairment): Total serum bilirubin > 1.5 times the upper limit of normal (ULN) (> 3 × ULN for patients with Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5 times ULN (if liver test abnormalities are due to hepatic metastases, AST or ALT = 5 × ULN).
–For patients entering from study MDV3800 02 (hepatic impairment): Inability to tolerate talazoparib 0.25 mg/day or had liver tests (bilirubin, AST, or ALT) that worsened to clinically significant values during the study.
•Bone marrow reserve: Absolute neutrophil count < 1500/µL, platelets < 100,000/µL, or hemoglobin < 9 g/dL (blood samples collected after at least 14 days without growth factor support or transfusion). Dose modification in the originating study is permitted to improve bone marrow reserve for eligibility.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To obtain additional safety data on long-term talazoparib use<br>;Secondary Objective: N/A;Primary end point(s): Safety;Timepoint(s) of evaluation of this end point: Safety will be evaluated at clinic visits approximately every 4 weeks for the first 24 weeks and then approximately every 8 weeks (additional visits for laboratory testing every 2 weeks through week 9 and every 4 weeks thereafter) or as clinically indicated.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A