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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00526617 |
A Phase 1, multicenter, dose-escalation study evaluating the safety and tolerability of the PARP inhibitor ABT-888 in combination with Temozolomide in subjects with metastatic melanoma and non-hematologic malignancies, including BRCA deficient breast and ovarian cancer.
Condition | Intervention | Phase |
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Non-Hematologic Malignancies (Solid Tumor) Metastatic Melanoma (MM) BRCA Deficient Breast Cancer BRCA Deficient Ovarian Cancer |
Drug: ABT-888 Drug: Temozolomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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) |
Estimated Enrollment: | 36 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Open Label: Experimental
Within each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ.
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Drug: ABT-888
Oral capsules
Drug: Temozolomide
Oral capsules
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Dose escalation and expanded safety cohorts
Expanded safety cohorts only
Exclusion Criteria:
Dose escalation and expanded safety cohorts
Expanded Safety Cohorts Only
Contact: Debra L Rehwinkel | (847) 937-5254 | debra.rehwinkel@abbott.com |
Contact: Betsy B Gamlin | (847) 938-3630 | betsy.gamlin@abbott.com |
United States, Arizona | |
Mayo Clinic Arizona | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
Contact: Mayo Clinic Clinical Trials Referral Office 507-538-7623 | |
United States, Minnesota | |
Mayo Clinic Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Mayo Clinic Clinical Trials Referral Office 507-538-7623 |
Responsible Party: | Abbott ( Joyce Steinberg, MD, Global Medical Director ) |
Study ID Numbers: | M06-862 |
Study First Received: | September 5, 2007 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00526617 |
Health Authority: | United States: Food and Drug Administration |
Solid Tumor Melanoma BRCA deficient breast and ovarian cancer |
Temozolomide (TMZ) ABT-888 Mayo Clinic |
Ovarian cancer Ovarian Neoplasms Skin Diseases Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Breast Neoplasms Urogenital Neoplasms Ovarian Diseases Temozolomide Melanoma |
Neuroendocrine Tumors Genital Diseases, Female Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Endocrinopathy Nevus Breast Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions Adnexal Diseases |