A Study of ZN-c3 in Patients With Ovarian Cancer

Phase 1

Recruiting

• Conditions: Peritoneal Cancer; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Solid Tumor
• Interventions: Drug: ZN-c3; Drug: Pegylated liposomal doxorubicin; Drug: Paclitaxel; Drug: Carboplatin; Drug: Gemcitabine; Biological: Bevacizumab

• Registration Number: NCT04516447
• Lead Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Brief Summary

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-18
• Study Start: 2020-10-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2024-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.

• Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting.

• Measurable disease per RECIST version 1.1.

• Adequate hematologic and organ function as defined by the following criteria:

  1. ANC ≥ 1.5 × 10^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
  2. Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 days after transfusion of platelets or within 3 weeks after administration of platelet growth factors.
  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT ≤ 5 x ULN.
  4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
  5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.

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Exclusion Criteria

• Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.

• Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:

  1. Major surgery within 28 days.
  2. Radiation therapy within 21 days.
  3. Autologous or allogeneic stem cell transplant within 3 months.

A serious illness or medical condition(s) including, but not limited to, the following:

1. Brain metastases that require immediate treatment or are clinically or radiographically unstable.

2. Myocardial impairment of any cause.

3. Significant gastrointestinal abnormalities.

4. Active or uncontrolled infection.

5. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day 1.

   • Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination with PLD	Pegylated liposomal doxorubicin	combined with azenosertib
Combination with carboplatin	ZN-c3	combined with azenosertib
Combination with bevacizumab	ZN-c3	combined with azenosertib
Combination with gemcitabine	ZN-c3	combined with azenosertib
Combination with PLD	ZN-c3	combined with azenosertib
Combination with paclitaxel	ZN-c3	combined with azenosertib
Combination with paclitaxel	Paclitaxel	combined with azenosertib
Combination with carboplatin	Carboplatin	combined with azenosertib
Combination with gemcitabine	Gemcitabine	combined with azenosertib
Combination with bevacizumab	Bevacizumab	combined with azenosertib

Primary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab	Through completion, approximately 40 months	Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine	Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, gemcitabine, or bevacizumab)	Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1

Trial Locations

Locations (24)

Site 2716; 🇦🇺 Melbourne, Victoria, Australia

Site 0264; 🇺🇸 Aurora, Colorado, United States

Site 0104; 🇺🇸 Boston, Massachusetts, United States

Site 0111; 🇺🇸 Saint Louis, Missouri, United States

Site 0173; 🇺🇸 New York, New York, United States

Site 0259; 🇺🇸 Durham, North Carolina, United States

Site 0191; 🇺🇸 Providence, Rhode Island, United States

Site 0196; 🇺🇸 Nashville, Tennessee, United States

Site 0103; 🇺🇸 Houston, Texas, United States

Site 2707; 🇦🇺 South Brisbane, Queensland, Australia

Site 2708; 🇦🇺 Sunshine Coast, Queensland, Australia

Site 2709; 🇦🇺 Adelaide, South Australia, Australia

Site 2706; 🇦🇺 Melbourne, Victoria, Australia

Site 2705; 🇦🇺 Nedlands, Western Australia, Australia

Site 1001; 🇧🇦 Banja Luka, Bosnia and Herzegovina

Site 1002; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Site 1003; 🇧🇦 Tuzla, Bosnia and Herzegovina

Site 1202; 🇧🇬 Panagyurishte, Bulgaria

Site 1201; 🇧🇬 Sofia, Bulgaria

Site 1401; 🇬🇪 Tbilisi, Georgia

Site 2901; 🇰🇷 Busan, Korea, Republic of

Site 2903; 🇰🇷 Seoul, Korea, Republic of

Site 2904; 🇰🇷 Seoul, Korea, Republic of

Site 1902; 🇷🇸 Belgrade, Serbia