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Recruiting NCT04516447

A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

Phase I Interventional Solid Tumor Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel.
Who it may be relevant to
Registry conditions: Solid Tumor, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Bosnia and Herzegovina, Bulgaria, Georgia +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer

Overview

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.

Detailed description

This is a Phase 1b open-label, multicenter study evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (also known as ZN-c3) in combination with chemotherapy or bevacizumab. This study consists of 2 parts:

Part 1 (completed and no longer recruiting): Azenosertib in combination with chemotherapy Azenosertib was assessed in combination with chemotherapy in subjects with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer.

Part 2: Azenosertib in combination with bevacizumab

* Dose Escalation (completed and no longer recruiting): Azenosertib was assessed in combination with bevacizumab as first-line (1L) or second-line (2L) maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy to determine a recommended dose for expansion. * Dose Expansion: Azenosertib will be assessed in combination with bevacizumab as 2L maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy.

Interventions

  • Drug Azenosertib
    Investigational drug
  • Drug Carboplatin
    Carboplatin is an approved drug
  • Drug Pegylated liposomal doxorubicin
    Pegylated liposomal doxorubicin (PLD) is an approved drug
  • Drug Paclitaxel
    Paclitaxel is an approved drug
  • Drug Gemcitabine
    Gemcitabine is an approved drug
  • Biological Bevacizumab
    Bevacizumab is an approved drug

Primary outcome measures

  • Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine [Time frame: Through study completion, an average of 1 year]
  • Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine [Time frame: Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, or gemcitabine)]
  • Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab [Time frame: Through study completion, an average of 1 year]
  • Part 2: To identify the recommended dose for Part 2 Dose Expansion [Time frame: Through Cycle 1 (21 days)]

Eligibility criteria

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:

  • In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
  • In the 2L setting:
  • Progressive Disease >183 days after receiving the last dose of platinum chemotherapy in the 1L setting,
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Site 0264 — Aurora
  • Site 0104 — Boston
  • Site 0111 — St Louis
  • Site 0173 — New York
  • Site 0259 — Durham
  • Site 0191 — Providence
  • Site 0196 — Nashville
  • Site 0103 — Houston
Australia · 6 centers
  • Site 2707 — South Brisbane
  • Site 2708 — Sunshine Coast
  • Site 2709 — Adelaide
  • Site 2716 — Melbourne
  • Site 2706 — Melbourne
  • Site 2705 — Nedlands
Bosnia and Herzegovina · 3 centers
  • Site 1001 — Banja Luka
  • Site 1002 — Sarajevo
  • Site 1003 — Tuzla
South Korea · 3 centers
  • Site 2901 — Busan
  • Site 2903 — Seoul
  • Site 2904 — Seoul
Bulgaria · 2 centers
  • Site 1202 — Panagyurishte
  • Site 1201 — Sofia
Georgia · 1 center
  • Site 1401 — Tbilisi
Serbia · 1 center
  • Site 1902 — Belgrade

Identifiers

NCT: NCT04516447 · ZN-c3-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗