A Phase 1 study of oral TVB-2640 in Patients with Solid Tumours
Research type
Research Study
Full title
A Phase 1, first-in-human study of escalating doses of oral TVB-2640 in patients with solid tumours
IRAS ID
164984
Contact name
Julian Lipscombe
Contact email
Sponsor organisation
3-V Biosciences
Eudract number
2014-002051-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
TVB-2640 is a drug designed to inhibit the enzyme fatty acid synthase (FASN). FASN is found in many cancer types (e.g. breast, ovarian, prostate, colon, pancreatic cancers and non-Hodgkins Lymphoma) and has been associated with increased patient death. Recent studies have shown FASN inhibition can restore sensitivity to many types of chemotherapy drugs.
The study will be carried out in Phase 1 research centres and will look at TVB-2640 given alone and in combination with selected, commercially available anticancer/chemotherapy drugs. In the combination cohort(s), TVB-2640 will be given with one of the following anticancer agents:
? Taxanes (e.g., Paclitaxel, Docetaxel)
? Gemcitabine
? Topoisomerase inhibitors (e.g., Irinotecan, Topotecan)
? Platinum agents (e.g., Cisplatin, Oxaliplatin, Carboplatin)Patients can have as many cycles of 3 weeks (or 4 weekly if given in combination with certain commercially available anticancer agents whose cycle length is 4 weekly) before they meet the withdrawal criteria. Phase 1 of the study will be carried out in the U.S. and U.K. and will recruit 131 patients over approximately 10 sites worldwide. The study is expected to last 2 years in the U.K.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/2024
Date of REC Opinion
12 Jan 2015
REC opinion
Further Information Favourable Opinion