An Open-Label Pharmacokinetics and Safety Study of Talazoparib

NCT ID: NCT02997163

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2019-01-30

Brief Summary

This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumors and impaired renal 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 after discussion with the Principal Investigator and obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with talazoparib in an open-label extension study will be based on potential overall benefit-risk, patient acceptance and other relevant criteria.

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 renal function)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Daily oral doses of talazoparib 0.5 mg

Group B (mild renal impairment)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Daily oral doses of talazoparib 0.5 mg

Group C (moderate renal impairment)

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Daily oral doses of talazoparib 0.5 mg

Group D (severe renal impairment)

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) obtained prior to initiation of any study-specific procedure and treatment.

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

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

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

5. Expected life expectancy of ≥ 3 months.

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

7. Renal function at screening and enrollment as defined by the Modification of Diet in Renal Disease (MDRD) equation.

8. Patient has had no clinically significant change in renal status within 3 months prior to screening, according to Investigator's review of clinical patient records.

9. Patient is not currently on hemodialysis and/or peritoneal dialysis for management of chronic kidney disease or acute failure/conditions.

10. Patient has no unstable renal function, defined as a change in estimated glomerular filtration rate (eGFR) (calculated with the MDRD equation) of > 25% for patients with mild and moderate renal impaired or as a change in eGFR > 30% for patients with severe renal impaired, from screening to enrollment.

11. Adequate other organ function at screening and enrollment.

12. Female patients of childbearing potential must have a negative serum pregnancy test at screening, and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after the last dose of study drug.

13. 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 105 days after last dose of study drug.

14. Female patients must not be breastfeeding at screening nor during the study participation until 45 days after the last dose of study drug.

15. 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 with any type of systemic anticancer-therapy or any investigational drug, whichever is longer.

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 undergoing or requiring treatment.

6. Symptomatic or impending spinal cord compression or cauda equina 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 CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

References

Durairaj C, Chakrabarti J, Ferrario C, Hirte HW, Babu S, Piha-Paul SA, Plotka A, Hoffman J, Shi H, Wang DD. The Effect of Renal Impairment on the Pharmacokinetics and Safety of Talazoparib in Patients with Advanced Solid Tumors. Clin Pharmacokinet. 2021 Jul;60(7):921-930. doi: 10.1007/s40262-020-00983-y. Epub 2021 Mar 9.

Reference Type: DERIVED

PMID: 33686631 (View on PubMed)

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=MDV3800-01

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

Other Identifiers

C3441001

Identifier Type: OTHER

Identifier Source: secondary_id

2016-002536-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MDV3800-01

Identifier Type: -

Identifier Source: org_study_id