An open label study to provide extended treatment in patients treated with Talazoparib.

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2016-001972-31-HU
• Date of registration: 11/07/2016
• Prospective Registration: Yes
• Primary sponsor: Medivation, Inc.
• Public title: An open label study to provide extended treatment in patients treated with Talazoparib.
• Scientific title: A Single Arm, Open Label, Multicenter, Extended Treatment, Safety Study in Patients Treated With Talazoparib
• Date of first enrolment: 18/08/2016
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001972-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, France, Germany, Hungary, Moldova, Republic of, Poland, Russian Federation, United Kingdom, United States

Contacts

• Name: Medical Officer
• Affiliation: Medivation, Inc.

• Name: Medical Officer
• Affiliation: Medivation, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
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 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 45 days 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 105 days 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 45 days 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 105 and 45 days, 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

Exclusion criteria:
1.Permanently discontinued from any Medivation 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 protocol.
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 protocol.
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Advanced solid tumors

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: Talazoparib
Product Code: MDV3800 (BMN 673)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N/A
CAS Number: 1373431-65-2
Current Sponsor code: MDV3800 (BMN673)
Other descriptive name: MDV3800 (BMN 673)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Product Name: Talazoparib
Product Code: MDV3800 (BMN 673)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N/A
CAS Number: 1373431-65-2
Current Sponsor code: MDV3800 (BMN673)
Other descriptive name: MDV3800 (BMN 673)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Primary Outcome(s)

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 thereafter or as clinically indicated.

Main Objective: To offer extended open label treatment to patients treated with talazoparib in qualifying studies
To obtain additional safety data on talazoparib use

Secondary Objective: N/A

Primary end point(s): Safety

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

2016-001972-31-GB

MDV3800-13

Source(s) of Monetary Support

Medivation, Inc.

Ethics review

Status: Approved
Approval date: 16/08/2016
Contact: