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

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ClinicalTrials.gov Identifier: NCT02997176
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Talazoparib Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-label Pharmacokinetics And Safety Study Of Talazoparib (mdv3800) In Patients With Advanced Solid Tumors And Normal Or Varying Degrees Of Hepatic Impairment
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : May 27, 2020
Estimated Study Completion Date : May 27, 2020

Arm Intervention/treatment
Experimental: Group A (control, normal hepatic function) Drug: Talazoparib
Daily oral doses of talazoparib 0.5 mg
Other Names:
  • MDV3800
  • BMN673

Experimental: Group B (mild hepatic dysfunction) Drug: Talazoparib
Daily oral doses of talazoparib 0.5 mg
Other Names:
  • MDV3800
  • BMN673

Experimental: Group C (moderate hepatic dysfunction) Drug: Talazoparib
Daily oral doses of talazoparib 0.5 mg
Other Names:
  • MDV3800
  • BMN673

Experimental: Group D (severe hepatic dysfunction) Drug: Talazoparib
Daily oral doses of talazoparib 0.5 mg
Other Names:
  • MDV3800
  • BMN673




Primary Outcome Measures :
  1. Pharmacokinetics of talazoparib as assessed by trough plasma concentrations [ Time Frame: Anticipated in about 1 year following first patient enrolled ]

Secondary Outcome Measures :
  1. Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug. [ Time Frame: Anticipated in about 1 year following first patient enrolled ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 45 days 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 105 days after last dose of study drug.
  11. Female patients must not be breastfeeding at screening nor during the study participation until 45 days 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997176


Contacts
Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, California
UCLA Hematology/Oncology - Alhambra Recruiting
Alhambra, California, United States, 91801
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare Recruiting
Fullerton, California, United States, 92835
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. Recruiting
Los Angeles, California, United States, 90095-7349
Ronald Reagan UCLA Medical Center, Drug Information Center Recruiting
Los Angeles, California, United States, 90095
TRIO-US Central Administration Recruiting
Los Angeles, California, United States, 90095
UCLA Hematology/Oncology Recruiting
Los Angeles, California, United States, 90095
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. Recruiting
Los Angeles, California, United States, 90095
UCLA Hematology/Oncology - Porter Ranch Recruiting
Porter Ranch, California, United States, 91326
UCLA Hematology/Oncology - Santa Monica Recruiting
Santa Monica, California, United States, 90404
UCLA Torrance Oncology Recruiting
Torrance, California, United States, 90505
UCLA Hematology/Oncology - Santa Clarita Recruiting
Valencia, California, United States, 91355
United States, Florida
Orlando Health, Inc. Recruiting
Orlando, Florida, United States, 32806
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02997176     History of Changes
Other Study ID Numbers: MDV3800-02
C3441002 ( Other Identifier: Alias Study Number )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Talazoparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents