Trials / Completed
CompletedNCT00526617
A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients
A Phase I Study of ABT-888 in Combination With Temozolomide (TMZ) in Subjects With Non-Hematologic Malignancies (NHM) and Metastatic Melanoma (MM)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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).
Conditions
- Non-hematologic Malignancies
- Metastatic Melanoma
- Breast Cancer
- Ovarian Cancer
- Primary Peritoneal Cancer
- Fallopian Tube Cancer
- Hepatocellular Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-888 | Oral capsules |
| DRUG | Temozolomide | Oral capsules |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2010-06-01
- First posted
- 2007-09-10
- Last updated
- 2017-11-21
Source: ClinicalTrials.gov record NCT00526617. Inclusion in this directory is not an endorsement.