An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)

NCT ID: NCT02997176

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-02-12

Brief Summary

This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.

Detailed Description

At the end of the study, patients with no clinically significant toxicities, no contraindications to continue treatment with talazoparib, and no disease progression (underlying cancer progression) may be eligible to continue talazoparib treatment in a separate open-label extension study. The decision to allow the patient to continue dosing with talazoparib in an open-label extension (OLE) study will be based on potential overall benefit-risk and patient meeting eligibility criteria for OLE.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (control, normal hepatic function)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Daily oral doses of talazoparib 0.5 mg

Group B (mild hepatic dysfunction)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Daily oral doses of talazoparib 0.5 mg

Group C (moderate hepatic dysfunction)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Daily oral doses of talazoparib 0.5 mg

Group D (severe hepatic dysfunction)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Daily oral doses of talazoparib 0.5 mg

Interventions

Talazoparib

Daily oral doses of talazoparib 0.5 mg

Intervention Type: DRUG

Other Intervention Names

MDV3800; BMN673

Eligibility Criteria

Inclusion Criteria

1. Signed and dated Informed Consent Form (by the patient or a legally acceptable representative as per the local regulations).

2. Female or male at least 18 years of age.

3. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the Investigator

4. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.

5. Expected life expectancy of ≥ 3 months.

6. Able to swallow the study drug (no contraindication to oral agents).

7. Hepatic function at screening and enrollment as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria.

8. Adequate other organ function at screening and enrollment.

9. Female patients of childbearing potential must have a negative serum pregnancy test at screening and must agree to use a highly effective form of contraception from the time of the first dose of study drug through 7 months after the last dose of study drug.

10. Male patients must agree to use a condom when having sex with a pregnant woman or with a non-pregnant female partner of childbearing potential, from 21 days before the first dose of study drug through 4 months after last dose of study drug.

11. Female patients must not be breastfeeding at screening nor during the study participation until 7 months after the last dose of the study drug.

12. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria

1. Treatment within 14 days or five half lives prior to enrollment whichever is longer with any type of systemic anticancer-therapy or any investigational drug

2. Have not recovered (recovery is defined as CTCAE grade ≤ 1) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.

3. Major surgery within 28 days prior to enrollment.

4. Serious accompanying cardiac disorder

5. Active known or suspected brain metastasis or active leptomeningeal disease needing treatment

6. Symptomatic or impending spinal cord compression or cauda equine syndrome

7. Has undergone a liver transplant, kidney transplant or nephrectomy.

8. Prior allergic reaction or severe intolerance (meeting the criteria for a serious adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly ADP ribose polymerase (PARP) inhibitor.

9. Known myelodysplastic syndrome

10. Seropositive for human immunodeficiency virus (HIV).

11. Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.

12. Gastrointestinal disorder affecting absorption.

13. Known or suspected hypersensitivity to any of the talazoparib capsule components.

14. Any condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Medical Monitor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medivation, Inc.

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

UCLA Hematology/Oncology - Alhambra

Alhambra, California, United States

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

St. Joseph Heritage Healthcare

Fullerton, California, United States

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Fullerton, California, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

UCLA Hematology/Oncology - Porter Ranch

Porter Ranch, California, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

UCLA Torrance Oncology

Torrance, California, United States

UCLA Hematology/Oncology - Santa Clarita

Valencia, California, United States

Orlando Health, Inc.

Orlando, Florida, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=MDV3800-02

To obtain contact information for a study center near you, click here.

Other Identifiers

C3441002

Identifier Type: OTHER

Identifier Source: secondary_id

MDV3800-02

Identifier Type: -

Identifier Source: org_study_id