A Study of Talazoparib in Patients With Advanced Solid Tumors

NCT03070548

Last updated date
Study Location
PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely
Budapest, , 1077, Hungary
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. At least 18 years of age 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. Eastern Co-Operative Oncology Group (ECOG) performance status ≤ 2 at screening and Day -1.

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 of childbearing potential using a highly effective form of contraception, and female subjects should not donate eggs from the time point of 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 from 21 days before the first dose of study drug through 105 days after the last dose of study drug, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.

8. Female patients 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Treatment within 14 weeks or five half-live 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. Patients 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 solution components.


11. Use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BRCP
within 7 days or 5 half-lives, whichever is longer, before Day 1.


12. 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]).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Talazoparib in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Open-label Study Of 14c-labeled Talazoparib In Patients With Advanced Solid Tumors
Brief Summary This study will evaluate the mass balance of talazoparib after a single dose of talazoparib.
Detailed Description Patients participating in this study with no clinically significant toxicities may be eligible to continue treatment on a separate extension protocol after discussion with the Principal Investigator and obtaining Sponsor permission..
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: Talazoparib
1 mg of talazoparib containing100 ?Ci of 14C-radiolabeled talazoparib
Other Names:
  • MDV3800
  • BMN673
Study Arms  ICMJE Experimental: ADME
1 mg talazoparib containing100 ?Ci of 14C-radiolabeled talazoparib
Intervention: Drug: Talazoparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2017)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 18 years of age 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. Eastern Co-Operative Oncology Group (ECOG) performance status ? 2 at screening and Day -1.
  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 of childbearing potential using a highly effective form of contraception, and female subjects should not donate eggs from the time point of 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 from 21 days before the first dose of study drug through 105 days after the last dose of study drug, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.
  8. Female patients 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 weeks or five half-live 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. Patients 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 solution components.
  11. Use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BRCP within 7 days or 5 half-lives, whichever is longer, before Day 1.
  12. 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]).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070548
Other Study ID Numbers  ICMJE MDV3800-03
C3441003 ( Other Identifier: Alias Study Number )
2016-001394-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP