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Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Scottsdale Healthcare
Scottsdale, Arizona, 85258 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced or Recurrent Solid Tumors, Breast Neoplasms, Epithelial Ovarian Cancer, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer
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

- Histologically or cytologically documented, unresectable, locally advanced or
metastatic solid tumor

- Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].

- 18 years of age or older.

- Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1)
or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9
(pancreatic cancer).

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

- Have adequate organ function

- Able to take oral medications.

- Willing and able to provide informed consent.

- Sexually active patients must be willing to use an acceptable method of contraception.

- Females of childbearing potential must have a negative serum pregnancy test at
screening.

- Willing and able to comply with all study procedures.

Part 2 Dose Expansion Tumor Types:

- Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who
have received no more than 4 prior regimens for metastatic disease.

- Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations
who have received no more than 2 prior regimens for metastatic disease.

- Small cell lung cancer (SCLC) patients who have received no more than one prior
regimen for SCLC.

- Ewing's sarcoma patients who have received no more than 3 prior regimens for
metastatic disease.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Part 2 Expansion: Prior treatment with a PARP inhibitor.

- Has history of central nervous system (CNS) metastasis.

* Exception: In patients with SCLC, history of adequately treated brain metastasis who
do not require corticosteroids for management of CNS symptoms.

- Has had major surgery within 28 days before Cycle 1, Day 1.

- Has active peptic ulcer disease.

- Active gastrointestinal tract disease with malabsorption syndrome.

- Pregnant or breastfeeding at screening or planning to become pregnant (in each case,
either oneself or one's partner) at any time during the study.

NCT01286987
Pfizer
Completed
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

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Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors
This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced or Recurrent Solid Tumors
  • Breast Neoplasms
  • Ovarian Cancer, Epithelial
  • Ewing Sarcoma
  • Small Cell Lung Carcinoma
  • Prostate Cancer
  • Pancreas Cancer
Drug: Talazoparib
Oral capsule with multiple dosage forms given once daily
Other Names:
  • BMN 673
  • MDV3800
Experimental: Talazoparib
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
113
January 30, 2017
March 31, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor
  • Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
  • 18 years of age or older.
  • Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) or increased CA-125 (ovarian cancer) or PSA (prostate cancer) and/or CA 19-9 (pancreatic cancer).
  • Eastern Cooperative Oncology Group (ECOG) performance status ? 1.
  • Have adequate organ function
  • Able to take oral medications.
  • Willing and able to provide informed consent.
  • Sexually active patients must be willing to use an acceptable method of contraception.
  • Females of childbearing potential must have a negative serum pregnancy test at screening.
  • Willing and able to comply with all study procedures.

Part 2 Dose Expansion Tumor Types:

  • Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease.
  • Prostate or pancreatic cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 2 prior regimens for metastatic disease.
  • Small cell lung cancer (SCLC) patients who have received no more than one prior regimen for SCLC.
  • Ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease.

Exclusion Criteria:

  • Part 2 Expansion: Prior treatment with a PARP inhibitor.
  • Has history of central nervous system (CNS) metastasis.

    * Exception: In patients with SCLC, history of adequately treated brain metastasis who do not require corticosteroids for management of CNS symptoms.

  • Has had major surgery within 28 days before Cycle 1, Day 1.
  • Has active peptic ulcer disease.
  • Active gastrointestinal tract disease with malabsorption syndrome.
  • Pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT01286987
PRP-001
2010-023062-40 ( EudraCT Number )
C3441007 ( Other Identifier: Alias Study Number )
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Medical Director Medivation, Inc.
Pfizer
July 2017

ICMJE     Data element required by the

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

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