A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

NCT ID: NCT03077607

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-07
• Study Completion Date: 2018-01-20

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).

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

Arm A

Subjects will receive a 0.5 mg talazoparib and 100 mg itraconazole.

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose

Itraconazole

Intervention Type: DRUG

100 mg oral dose

Arm B

Subjects will receive 1 mg talazoparib and 600 mg rifampin.

Group Type: EXPERIMENTAL

Talazoparib

Intervention Type: DRUG

Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose

Rifampin

Intervention Type: DRUG

600 mg oral dose

Interventions

Talazoparib

Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose

Intervention Type: DRUG

Itraconazole

100 mg oral dose

Intervention Type: DRUG

Rifampin

600 mg oral dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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].

• 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

PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely

Budapest, , Hungary

ARENSIA Exploratory Medicine Phase I Unit, PMSI Institute of Oncology

Chisinau, , Moldova

Szpital LUX MED

Warsaw, , Poland

I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

I.M. Sechenov First Moscow State Medical University

Moscow, , Russia

"BioEq" LLC

Saint Petersburg, , Russia

State budget healthcare institution of Yaroslavl region "Regional clinical oncology hospital"

Yaroslavl, , Russia

Countries

Hungary; Moldova; Poland; Russia

References

Elmeliegy M, Lang 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.

Reference Type: DERIVED

PMID: 31770456 (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=MDV3800-04

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

Other Identifiers

C3441004

Identifier Type: OTHER

Identifier Source: secondary_id

2016-001813-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MDV3800-04

Identifier Type: -

Identifier Source: org_study_id