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A Study of Talazoparib in Patients With Advanced Solid Tumors

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely
Budapest, , 1077 Hungary
Contact
1-800-718-1021
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]).

NCT03070548
Pfizer
Completed
A Study of Talazoparib in Patients With Advanced Solid Tumors

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Masking: None (Open Label)
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Drug: Talazoparib
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Other Names:
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Experimental: ADME
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Intervention: Drug: Talazoparib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
June 30, 2017
June 1, 2017   (Final data collection date for primary outcome measure)

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]).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
 
NCT03070548
MDV3800-03
C3441003 ( Other Identifier: Alias Study Number )
2016-001394-33 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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