A Phase 1 Study of ABT-263 and Taxotere in Subjects with Solid Tumours

• Research type

  Research Study

• Full title

  A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Taxotere ® (docetaxel) in the Treatment of Subjects with Solid Tumours

• IRAS ID

  7846

• Contact name

  L Rhoda Molife

• Sponsor organisation

  Abbott GmbH & Co. KG

• Eudract number

  2008-001477-15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  One of the mechanisms that cancers use to grow uncontrollably is by evading the body's process whereby damaged cells die by a process called apoptosis. A group of proteins called Bcl-2 are known to stop this type of cell death, and are found in abundance in some cancers. ABT-263 works by stopping the action of Bcl-2 proteins and ensuring that cancer cells die, as any damaged cell should. It is a potential treatment for cancers, as it has been shown, in laboratory experiments to help kill human cancer cells. Docetaxel is a licensed chemotherapy used either alone or in combination with other chemotherapies for the treatment of various cancers. It is known that combination treatments have shown better response rates compared with single therapy treatments. In laboratory experiments ABT-263 was found to have an improved effect when combined with docetaxel. Both drugs can work better together to drive cancer cell death. This study will 1) define the safety of ABT-263 when given with docetaxel in patients with solid tumours 2) define the maximum dose of ABT-263 that can be given with docetaxel that a patient can tolerate 3) define the pharmacokinetics of ABT-263 (how quickly ABT-263 gets into the blood stream and how long it takes to clear). 4) gather preliminary information on how effective the combination of ABT-263 and docetaxel may be. The clinical safety of the combination of ABT-263 and docetaxel is not known. It is not certain that patients in this study will benefit from taking ABT-263. Information gathered may help improve future treatment of the disease. Patients will attend hospital visits throughout the study: these will be most frequent during the first cycle of treatment. At these visits they will undergo assessments to check on their safety and see how the drug is working.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  08/H0801/138

• Date of REC Opinion

  21 Oct 2008

• REC opinion

  Favourable Opinion