Phase Ib/II study of CYT997 and Carboplatin in relapsed GBM
Research type
Research Study
Full title
A Phase Ib/II Study of CYT997 in Combination with Carboplatin in Relapsed Glioblastoma Multiforme.
IRAS ID
32788
Contact name
Swethajit Biswas
Sponsor organisation
Cytopia Research Pty Ltd
Eudract number
2009-015696-28
Clinicaltrials.gov Identifier
Research summary
This is a Phase Ib/II study of CYT997 in combination with carboplatin in treatment of relapsed Glioblastoma Multiforme. Phase Ib is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of CYT997 administered as a 24-hour continuous intravenous (IV) infusion once every 3 weeks in combination with a fixed dose of carboplatin administered as a 1-hour IV infusion once every 3 weeks. Dose escalation will occur in 3 to 6 subjects to determine the maximum tolerated regime of CYT997 in combination with carboplatin. At the maximum tolerated regime the cohort will be expanded to include 3 more subjects to further assess safety, tolerability and PK, so that 6 patients in total are treated at the recommended dose (RD). Phase II will further evaluate the efficacy, safety and tolerability of the CYT997 and carboplatin combination using the RD established in the Phase Ib part of the study. An initial group of 10 subjects will be treated (including the 6 subjects treated during the Phase Ib part of the study at the RD) and, if 2 of these subjects are alive and progression-free at 6 months, recruitment will continue to a total of 29 subjects. Subjects will be followed for response, disease progression and survival. Treatment will continue until disease progression, unacceptable toxicities, or intercurrent illness that prevents further administration of treatment.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
10/H0906/1
Date of REC Opinion
24 Mar 2010
REC opinion
Further Information Favourable Opinion