Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02903771 | Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer. | PHASE1 | COMPLETED | 32 | — | — | Dec 5, 2016 | Mar 24, 2020 | Sep 19, 2024 | 6 | United States, Australia |
Determination of the MTD: At each dose level, the number and proportion of patients in the MTD population who experience a dose-limiting toxicity (DLT) during the DLT evaluation period (Cycle 1/Part A) of Cantrixil using standard safety monitoring assessments when administered as a monotherapy. The MDT was the dose level below the cohort in which 1 or more patients had experienced a DLT.
Mean plasma concentration
| Arm | Type | Description |
|---|---|---|
| Part A and Part B | EXPERIMENTAL | Part A (Dose Escalation): Part A is a Dose Escalation study to determine the Maximum Tolerated Dose of Cantrixil as a monotherapy. The tolerance of Cantrixil in combination with standard chemotherapy agents will also be examined. Part B (Expansion Cohort): An expansion cohort of an additional 12 patients will be recruited at the MTD. |
| Name | Type | Description |
|---|---|---|
| Part A: Dose Escalation of Cantrixil | DRUG | 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 | DRUG | 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. |
Inclusion Criteria: 1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The original diagnosis must be verified by a histology report. All histological sub-types and all grades of disease are eligible to participate; grade, histological su...