Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 5, 2016

Primary Completion Date

March 24, 2020

Study Completion Date

March 24, 2020

Conditions
Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms
Interventions
DRUG

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."

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.

Trial Locations (6)

2145

Westmead Adults Hospital, Westmead

4101

ICON Cancer Care, South Brisbane

73104

Peggy and Charles Stephenson Cancer Center, OU Health Sciences Center, Oklahoma City

75230

Mary Crowley Cancer Research Center, Dallas

02903

Lifespan Cancer Institute, Rhode Island Hospital, Providence

Unknown

Flinders Medical Centre, Adelaide

Sponsors
All Listed Sponsors
lead

Kazia Therapeutics Limited

INDUSTRY

NCT02903771 - Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. | Biotech Hunter | Biotech Hunter