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A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

Inclusion Criteria:

- Subject must be 18 years of age.

- Histologically or cytologically confirmed solid tumors that are metastatic or
unrespectable for which carboplatin/gemcitabine is a treatment option.

- Eastern Cooperative Group performance score of 0 to 2.

- Adequate hematologic, hepatic and renal function

- Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five

Exclusion Criteria:

- Subject has received any anti-cancer therapy including chemotherapy, immunotherapy,
radiotherapy, biologic or any investigational therapy within 28 days prior to study

- Subjects with known history of brain metastases and primary CNS tumors.

- Hypersensitivity reactions to platinum compounds or gemcitabine.

- Clinically significant and uncontrolled major medical conditions

- Active malignancy within the past 5 years except for any cancer in situ cured or
non-melanoma carcinoma of the skin.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose and recommended Phase 2 dose

Outcome Time Frame:

ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).

Safety Issue:


Principal Investigator

Mark D McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Advanced Solid Tumors
  • PARP Inhibitors
  • Neoplasms



Site Reference ID/Investigator# 23283Duarte, California  91010
Site Reference ID/Investigator# 27743Duarte, California  91010
Site Reference ID/Investigator# 23284Chicago, Illinois  60637
Site Reference ID/Investigator# 23282New York, New York  10065
Site Reference ID/Investigator# 23286Philadelphia, Pennsylvania  19111
Site Reference ID/Investigator# 23285Seattle, Washington  98109-1023