At a glance
ClinicalIndex Comparison Record- ✓Recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer confirmed by histology
- ✓Female, ≥18 years old
- ✓Completed at least 2 or more prior therapies for ovarian, fallopian tube, or primary peritoneal cancer including prior intraperitoneal therapy if applicable
- ✓Platinum-resistant relapsed disease, platinum-refractory disease, or documented intolerance to platinum therapy with clinical symptoms or radiological evidence of progression (not CA-125 alone)
- ✕Chemotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for bevacizumab, nitrosoureas, or mitomycin C) prior to study entry
- ✕Major surgery within 4 weeks prior to screening
- ✕Other investigational medicinal products or interventional clinical research studies within 3 months of first Cantrixil administration
- ✕Strong inhibitors or inducers of CYP1A2, CYP2B6, and CYP3A4 or drugs with narrow therapeutic index (except paclitaxel allowed >24 hours after Cantrixil)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of Intra-peritoneal Cantrixil in Patients With Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.
In Brief
A Phase 1 clinical trial evaluating Part A: Dose Escalation of Cantrixil and Part B: Expansion Cohort of Cantrixil for Ovarian Neoplasms and 2 related conditions. Completed, enrolled 32 participants across 6 sites in 2 countries.
Detailed Summary
The main purpose of this study is to determine the safety and feasibility of weekly intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian cancer, Fallopian tube cancer or primary peritoneal cancer. The study also aims to determine the maximum tolerated dose of Cantrixil in these patients when administered as a monotherapy or a combination therapy.
Study Details
Timeline
Interventions
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.
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.