CA180-323: Phase 1B adult leukaemia dasatinib study (V1 28JUL10)

• Research type

  Research Study

• Full title

  A Phase 1b study of Dasatinib (BMS-354825) combined with SMO inhibitor (BMS-833923) in patients with Chronic Myeloid Leukaemia with resistance or suboptimal response to a prior tyrosine kinase inhibitor.

• IRAS ID

  56889

• Contact name

  Mhairi Copland

• Sponsor organisation

  Bristol Myers Squibb International Corporation

• Eudract number

  2010‐019480‐11

• ISRCTN Number

  N/A

• Research summary

  Chronic Myeloid Leukaemia (CML) is a type of leukaemia, which is a cancer of the blood forming system. CML usually develops very slowly, which is why it is called ??chronic?? myeloid leukaemia. CML is rare, affecting approximately 700 people (mostly adults) in the UK each year. Despite significant advances in the treatment of CML over the last decade, new treatment options are still needed. This study will investigate whether or not the combination of dasatinib and BMS-833923 is safe and tolerable. The study will also give some preliminary information as to whether the combination of these 2 drugs provides increased chances of achieving longer lasting disease control in CML patients. BMS-833923 is an anticancer drug in development. It is thought that this drug works by blocking an important pathway (the ??Hedgehog?? pathway) which is known to be involved in helping cancers grow.This study is looking for patients with CML who have developed resistance to imatinib or nilotinib or who have not had an adequate response to imatinib, nilotinib or dasatinib (all approved drugs for treating CML). Patients who meet all the entry criteria will enter the study and will receive both dasatinib and BMS-833923. Patients will undergo: physical examinations, multiple blood tests, chest x-rays, heart functions tests and bone marrow aspirates. Patients will be continually monitored and their treatment stopped if they do not respond or are unable to tolerate any side effects. Patients will continue in the study for at least 3 years or for longer if responding to therapy.Approximately 36-40 patients worldwide are expected to participate with about 5-6 taking part in the UK. The study is funded by Bristol-Myers Squibb and will be conducted in 2 UK hospitals ?? Beatson Oncology Centre, Glasgow and Royal Liverpool University Hospital. Globally, the study is planned to start in December 2010.

• REC name

  West of Scotland REC 1

• REC reference

  10/S0703/65

• Date of REC Opinion

  1 Mar 2011

• REC opinion

  Further Information Favourable Opinion