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Tracking Information | |||||||||
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First Received Date † | September 5, 2007 | ||||||||
Last Updated Date | May 11, 2009 | ||||||||
Start Date † | August 2007 | ||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
Maximum Tolerated Dose [ Time Frame: 6 Months ] | ||||||||
Change History | Complete list of historical versions of study NCT00526617 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients | ||||||||
Official Title † | A Phase I Study of ABT-888 in Combination With Temozolomide (TMZ) in Subjects With Non-Hematologic Malignancies (NHM) and Metastatic Melanoma (MM) | ||||||||
Brief Summary | This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Temozolomide (chemotherapy) in treating patients with solid tumors, including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC). |
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Detailed Description | A Phase 1, multicenter, dose-escalation study evaluating the safety and tolerability of the PARP inhibitor ABT-888 in combination with Temozolomide (TMZ) in subjects with non-hematologic malignancies (NHM), including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC). |
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Study Phase | Phase I | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | Experimental: Within each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ. | ||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 36 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria: Dose escalation and expanded safety cohorts
Expanded Safety Cohorts Only
Exclusion Criteria: Dose Escalation and Expanded Safety Cohorts
Lower Dose Expanded Safety Cohorts Only:
Expanded Safety Cohorts Only
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00526617 | ||||||||
Responsible Party | Vincent Giranda, M.D., Ph.D., Abbott | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Abbott | ||||||||
Collaborators †† | |||||||||
Investigators † | |||||||||
Information Provided By | Abbott | ||||||||
Verification Date | April 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |