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

This study is a progressive design with 2 discrete Parts (Part A: Dose escalation, Part B: Dose expansion. Cycle 1/Part A is a dose-finding assessment (dose escalation) to establish the maximum tolerated dose (MTD) of Cantrixil when administered as a single dose once a week for 3 weeks. Cycle2/Part A continues with 3 additional weekly doses of Cantrixil as a monotherapy before an assessment of disease response. In Cycles 3 to 8/Part A, patients will be administered the same once weekly dose of Cantrixil they tolerated in Cycles 1 and 2 (tolerance defined as no dose limiting toxicities \[DLTs\] or unacceptable treatment-related adverse events \[AEs\]) in combination with a limited range of standard chemotherapy agent(s), in order to assess the safety and tolerability of Cantrixil in combination therapy. Standard chemotherapy drugs will be administered at the standard efficacious doses to maintain optimum benefit of known drug combinations for patients.

Once the MTD has been determined in Part A, an additional 12 patients will be recruited in an expansion cohort for Part B. These patients will receive 2 cycles of Cantrixil monotherapy at the MTD, followed by up to 6 cycles of combination therapy.

Patients enrolled into the respective parts of the study may not receive treatments under different parts of the protocol.

To accommodate the intraperitoneal administration of Cantrixil, an in-dwelling, closed catheter or port will be inserted if the patient does not already have one. For intraperitoneal ports, the minimum period between port placement and the first administration of Cantrixil must not be shorter than 7 days.

Patients should begin protocol treatment within a maximum of 28 days of enrolment (i.e., signing of consent form).

Patients will start at Dose Level 0 which is calculated to be the human equivalent of 10% of the severely toxic dose in 10% (STD10) dose in rats (dose that is 1/10 the severely toxic dose in 10% of rats tested). Dose levels -1 and -2 will only be activated if there are 2 DLTs at the Dose Level 0 and -1, respectively. Single patient cohorts will be treated with increasing doses of Cantrixil until an AE is observed that meets the definition of a Dose Limiting Toxicity (DLT) or, in the opinion of the Data Safety Monitoring Committee (DSMC) and the Investigator, is causally related to study treatment and warrants observing additional patients at this dose level; at this point the study will revert to a 3+3 rules based dose escalation study. Once the study enters a 3+3 rules-based design, the study will not revert back to single patient cohorts.