A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy (NCT04814875) | Clinical Trial Compass
TerminatedPhase 1/2
A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy
Stopped: For technical reasons, it was decided by the sponsor to close the ongoing ovarian cancer study, AM ATX101-03, immediately.
Australia16 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women ≥ 18 years of age
✓. Is not a woman of childbearing potential:
✓. Surgically sterile (i.e., had a bilateral tubal ligation, hysterectomy, salpingectomy, or bilateral oophorectomy at least 6 months prior to Day 1 of the study) or;
✓. Postmenopausal for at least 1 year prior to Day 1 of the study, and have follicle stimulating hormone levels in the postmenopausal range for the study site.
✓. Signed written informed consent
✓. Histologically confirmed high grade serous or endometrioid carcinoma of the ovary, fallopian tube, or primary peritoneal cancer
✓. 1 to 3 prior systemic treatment lines. Prior maintenance therapy with bevacizumab or PARP inhibitors is permitted.
✓. Platinum-sensitive carcinoma, defined as disease progression after ≥ 6 months following the most recent platinum-based therapy of the disease
Exclusion criteria
✕
What they're measuring
1
Part 1: To determine the maximum tolerated dose (MTD) of ATX-101 in combination with carboplatin/pegylated liposomal doxorubicin. Measured by incidence of Dose Limiting Toxicity.
Timeframe: Assessed from the time of the first administered dose of ATX-101 up to the last treatment in Cycle 2 (i.e. Days 2 to 30).
2
Part 2: To assess the progression free survival (PFS) of ATX-101 in combination with carboplatin/pegylated liposomal doxorubicin. Measured by Tumor assessments.
. Have received an anti-cancer/investigational drug within 4 weeks prior to study drug administration
✕. Have received a vaccine for COVID-19 within 14 days prior to the first dose of ATX-101 or are scheduled/intend to have a COVID-19 vaccine on Day 1 or during the DLT period (i.e. C1D2 \[Day 2\] through to C2D2 \[Day 30\]) of the study
✕. Have not recovered from AEs (≥ CTCAE Grade 2 other than alopecia) due to agent(s) administered more than 4 weeks earlier
✕. Radiotherapy within 4 weeks prior to study drug administration
✕. Major surgery or significant trauma within 28 days (4 weeks) of Screening
✕. Anticipated requirement for surgery or initiation of anti-cancer therapy, other than described in this study protocol, during the study period
✕. Known hypersensitivity to any of the combination partners of ATX-101
✕. Any malignancy over the last 5 years, other than ovarian/fallopian tube/primary peritoneal cancer, with exception of basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that is considered cured by excision