This phase Ib/IIa trial is evaluating the safety and effectiveness of a drug designed to enhance the effectiveness of other treatments (ATX-101) when combined with platinum-based chemotherapy (carboplatin/pegylated liposomal doxorubicin [ACD]) in people with platinum-sensitive, recurrent ovarian, fallopian tube or primary peritoneal cancer.
This trial is treating patients with platinum-sensitive, recurrent ovarian, fallopian tube or primary peritoneal cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
Phase 1b/2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Commercial Sponsor
THERAPIM PTY LTD
Summary
This study has two parts. Part 1 is investigating the safety of the combination of ATX-101 with carboplatin/pegylated liposomal doxorubicin (ACD). ATX-101 will be administered intravenously in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design. In the case where 20 mg/m² is not tolerated, the dose can be de-escalated to 15 mg/m². Pegylated liposomal doxorubicin (30 mg/m²) will be administered intravenously on Day 1 of each 28-day cycle; carboplatin (AUC5) will be administered intravenously on Day 1 of each cycle. Part 2 will be further investigating the efficacy and safety of this combination. In this part, ATX-101 will be administered at the dose defined in part 1 of the study.
Recruiting Hospitals Read More