Trials / Terminated
TerminatedNCT04814875
A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy
Phase 1b/2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- THERAPIM PTY LTD · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1b/2a multicenter study, which consists of two parts: Part 1: the Phase 1b part of the study will investigate 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. Part 2: the Phase 2a part of the study will investigate the efficacy and safety of ACD. ATX-101 will be administered at the dose defined in Part 1 of the study. Treatment will continue up to six cycles or until disease progression or unacceptable toxicity, participant withdrawal of consent, non-compliance, lost to follow-up, or withdrawal at the Investigators discretion, whichever occurs first.
Conditions
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Carcinoma
- High Grade Serious or Endometrioid Carcinoma of the Ovary, Fallopian Tube, or Primary Peritoneal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD) | 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. ATX-101 will be administered intravenously on Day 2 of each cycle in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2021-03-24
- Last updated
- 2024-02-14
Locations
6 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT04814875. Inclusion in this directory is not an endorsement.