A Phase 2 Study of ABT-888 and Temozolomide in Metastatic Melanoma.
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination with Temozolomide Versus Temozolomide Alone in Subjects with Metastatic Melanoma.
IRAS ID
11702
Contact name
Mark Middleton
Sponsor organisation
Abbott GmbH & Co. KG
Eudract number
2008-004941-27
ISRCTN Number
NA
Clinicaltrials.gov Identifier
Research summary
The number of People'suffering from Metastatic (cancer that has spread) melanoma has been increasing over the past four decades. Few improvements have been made in the management of patients with advanced metastatic melanoma and limited treatment options are available for patients. ABT-888 is a PARP (Poly (ADP-ribose)-polymerase) inhibitor. PARP is a protein made by the body that may help cancer cells overcome injury or damage caused by radiation and certain types of cancer drugs, making these treatments not work as well. As ABT-888 blocks the activity of PARP this may prevent cancer cells from repairing themselves and growing again. ABT-888 is a potential treatment of patients with cancer when given with other anti-cancer drugs such as temozolomide.Temozolomide is a cancer treatment which is currently used to treat patients with metastatic melanoma.This study will assess whether combining ABT-888 and temozolomide is more effective than giving temozolomide alone to patients with metastatic melanoma. Patients in the study will receive either temozolomide with ABT-888 or temozolomide with placebo (a pill that does not contain active drug).It is not certain that patients in this study will benefit from taking ABT-888. Information gathered from this study may help improve future treatment of the disease.Patients will attend hospital visits throughout the study: these will be most frequent during the first two cycles of treatment. At these visits patients will undergo tests to check on their safety and see how the drug is working. The effect of the treatment on the cancer will be checked by having blood tests, scans, obtaining ongoing medical history and completing questionnaires. Patients will continue ABT-888 and temozolomide for as long as they are clinically benefiting and managing any side effects.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
09/H0606/12
Date of REC Opinion
11 Mar 2009
REC opinion
Further Information Favourable Opinion