A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/21/2016 |
Start Date: | January 2010 |
End Date: | March 2016 |
A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose of veliparib
(ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when
administered in combination with carboplatin and gemcitabine in subjects with advanced solid
tumors.
(ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when
administered in combination with carboplatin and gemcitabine in subjects with advanced solid
tumors.
Inclusion Criteria:
- 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.
We found this trial at
5
sites
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