Pegylated liposomal doxorubicin: Pegylated liposomal doxorubicin (PLD) is an approved drug
Paclitaxel: Paclitaxel is an approved drug
Gemcitabine: Gemcitabine is an approved drug
Bevacizumab: Bevacizumab is an approved drug
Study summary
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
INCLUSION CRITERIA:
For Part 1:
* Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.
* Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.
* The disease must be platinum resistant (ie, the PFI must have been \< 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.
For Part 2 Dose Escalation:
Prior therapy:
• Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy
Response to prior platinum therapy:
1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
2. In the 2L setting:
1. Progressive Disease \>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,
2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.
* Adequate hematologic, and organ function
For Part 2 Dose Expansion:
* Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease
* Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply
EXCLUSION CRITERIA:
* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
* Subjects with carcinosarcomas (even if there is a serous component)
* A serious illness or medical condition(s)
* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Additional protocol-defined exclusion criteria may apply
Primary outcome measure(s)
Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine — Through study completion, an average of 1 year Incidence and severity of adverse events (AEs)
Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine — Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, or gemcitabine) Incidence and severity of dose-limiting toxicities (DLTs)
Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab — Through study completion, an average of 1 year Incidence and severity of adverse events (AEs) Incidence of dose interruptions, reductions, and discontinuations due to treatment-related AEs
Part 2: To identify the recommended dose for Part 2 Dose Expansion — Through Cycle 1 (21 days)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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