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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
N/A
Open (Enrolling)
Both
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
years

Exclusion Criteria:

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

- 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:

Interventional

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:

Yes

Principal Investigator

Mark D McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M10-758

NCT ID:

NCT01063816

Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Advanced Solid Tumors
  • PARP Inhibitors
  • Neoplasms

Name

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