Study of DTX-SPL8783 in Combination with Anti-Cancer Treatments
Research type
Research Study
Full title
A Phase 1/2 Modular, Multi-Arm Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of DTX-SPL8783 (DEP docetaxel/DEP-DTX) in Combination with Anti-Cancer Treatments, in Patients with Advanced Malignancies
IRAS ID
275318
Contact name
James Spicer
Contact email
Sponsor organisation
Starpharma Pty Ltd
Eudract number
2019-004332-36
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The main purpose of this clinical trial is to assess the how safe it is to give the study drug (called DTX-SPL8783) in combination with other anticancer therapies and how well patients can tolerate such drug combinations in terms of side effects. The first drug to be combined with DTX-SPL8783 will be gemcitabine, a drug already in common as part of treatment of many different cancers. The trial includes two phases. In the first phase, the focus will be on safety and tolerability of the drug combination. In the second phase, we will assess not only will safety and tolerability, but whether the treatment results in improvement of the cancer, mostly by seeing if the tumour shrinks. The treatment will be given to the patients for as long as they continue to receive some clinical benefit.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0014
Date of REC Opinion
1 Feb 2020
REC opinion
Further Information Favourable Opinion