32
Participants
Start Date
December 5, 2016
Primary Completion Date
March 24, 2020
Study Completion Date
March 24, 2020
Part A: Dose Escalation of Cantrixil
"Cantrixil will be administered via the intraperitoneal route only. The dose of study drug that each participant will receive will depend on how far the study has progressed when the participant enrols. There are 9 potential doses of Cantrixil, they are 0.06, 0.12, 0.24 (starting dose), 0.6, 1.25, 2.5, 5, 10, or 20 mg/kg. The dose each participant receives will remain the same during the study, unless it needs to be reduced for safety reasons. The dose will not be increased.~Each participant will receive the study drug once a week during the first two cycles; each cycle is 21-days (three weeks); the MTD will be determined during Cycle 1 only. If after two cycles of monotherapy, the patient tolerates Cantrixil adequately, they may continue to receive Cantrixil once a week and will also begin combination chemotherapy for another 6 cycles. Participants will receive no more than 8 cycles of study drug."
Part B: Expansion Cohort of Cantrixil
Once the MTD has been established, an expansion cohort will be recruited at the MTD. An additional 12 patients will be recruited in this cohort on top of those recruited in Part A at the MTD. These patients will be subjected to the same intervention described in Part A with 2 cycles of monotherapy followed by up to 6 cycles of combination therapy.
Westmead Adults Hospital, Westmead
ICON Cancer Care, South Brisbane
Peggy and Charles Stephenson Cancer Center, OU Health Sciences Center, Oklahoma City
Mary Crowley Cancer Research Center, Dallas
Lifespan Cancer Institute, Rhode Island Hospital, Providence
Flinders Medical Centre, Adelaide
Lead Sponsor
Kazia Therapeutics Limited
INDUSTRY