CDI-CS-001B: BAL101553 in Patients with Advanced Solid Tumors(15Feb11)

• Research type

  Research Study

• Full title

  An Open-Label Phase I/IIa Study of Intravenous BAL101553 in Adult Patients with Advanced Solid Tumors

• IRAS ID

  73402

• Contact name

  Rebecca Kristeleit

• Sponsor organisation

  Basilea Pharmaceutica International Ltd.

• Eudract number

  2010-024237-23

• Clinicaltrials.gov Identifier

  NCT01397929.

• Research summary

  This is the first study of BAL101553 (called a Phase I study) to be conducted in humans. This means that the drug has shown promise in animal testing, but has not yet been used in people. BAL101553 will be administered intravenously on days 1, 8 and 15 of an every 28 day treatment cycle in adults with advanced or recurrent solid tumours, who have failed standard therapy or for whom no effective standard therapy is available.The study drug, BAL101553, is developed by the company Basilea Pharmaceutica International; it is experimental and therefore only available for use in clinical trials.Cancer is a condition in which cell growth is uncontrolled which leads to tumour formation. So-called microtubules are needed to help cells divide. BAL101553 stops microtubules from pulling dividing cells apart. If dividing cells fail to separate, the cells may die. The primary goal of the study is to find the highest dose of the study drug BAL101553 that can safely be given in humans and to assess what side effects might occur with BAL101553 treatment. The study will start with treating patients at low dose levels. Once it has been shown that a lower dose is well tolerated, new patients are included at higher dose levels (this part of the study is called ??dose escalation? and will include up to 39 patients). Once the highest dose that can be tolerated is identified, 20 additional patients will be put on that dose (this part is called ??dose expansion?) to further investigate how well BAL101553 is tolerated and further evaluate its effects. The study will also measure the amount of the drug and its metabolites in the body at different times and may also help understand how the drug is working and how effective it might be in treating cancer.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  11/EE/0092

• Date of REC Opinion

  6 May 2011

• REC opinion

  Further Information Favourable Opinion