Status:
TERMINATED
A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy
Lead Sponsor:
THERAPIM PTY LTD
Collaborating Sponsors:
Novotech (Australia) Pty Limited
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 lipos...
Eligibility Criteria
Inclusion
- 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
- Measurable disease on CT/MRI scan according to RECIST 1.1
- ECOG Performance status 0 to 1
- Life expectancy of at least 6 months
- Meet the following laboratory requirements:
- Hemoglobin (HGB) ≥ 100 × 109/L
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelet count ≥ 100 × 109/L
- aPTT/PT ≤ 1.5 x ULN
- Total bilirubin level ≤ 1.5 × ULN
- AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis present)
- Creatinine Clearance \> 60 mL/min, as calculated by Cockcroft-Gault formula, or serum creatinine ≤ 1.5 × ULN.
Exclusion
- 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
- Cardiac failure NYHA III/IV.
- LVEF \< 50% (ECHO or MUGA must not be older than 12 weeks)
- QTcF \> 470 msec
- Any organ dysfunction or current acute or chronic disease, other than the study indication, that would significantly increase the expected risk in participants participating in the study, in the judgment of the Investigator
- Pregnant or breast-feeding women
- Unwilling or unable to follow protocol requirements
- A past positive status of HIV and/or positive for HIV at Screening
- Active Hepatitis B or C. In participants with a history of Hepatitis B or Hepatitis C infection, HBsAg and HCV RNA tests have to be negative.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04814875
Start Date
September 1 2021
End Date
November 30 2023
Last Update
February 14 2024
Active Locations (6)
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1
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
2
Mater Misericordiae Limited
South Brisbane, Queensland, Australia, 4101
3
Peninsula and Southeast Oncology
Frankston, Victoria, Australia, 3199
4
Cabrini Hospital
Malvern, Victoria, Australia, 3144