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



Status:Completed
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:January 3, 2011
End Date:January 30, 2017

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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.


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.
We found this trial at
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Bloomington, Indiana
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
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Indianapolis, Indiana 46202
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Los Angeles, California 90095
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Los Angeles, California 90095
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Santa Monica, California 90404
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Scottsdale, Arizona 85259
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