A Study of ZN-c3 in Patients With Ovarian Cancer

NCT ID: NCT04516447

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-26

Study Completion Date

2027-02-28

Brief Summary

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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

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Conditions

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Solid Tumor Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination with carboplatin

combined with azenosertib

Group Type EXPERIMENTAL

ZN-c3

Intervention Type DRUG

Investigational drug

Carboplatin

Intervention Type DRUG

Carboplatin is an approved drug

Combination with PLD

combined with azenosertib

Group Type EXPERIMENTAL

ZN-c3

Intervention Type DRUG

Investigational drug

Pegylated liposomal doxorubicin

Intervention Type DRUG

Pegylated liposomal doxorubicin (PLD) is an approved drug

Combination with paclitaxel

combined with azenosertib

Group Type EXPERIMENTAL

ZN-c3

Intervention Type DRUG

Investigational drug

Paclitaxel

Intervention Type DRUG

Paclitaxel is an approved drug

Combination with gemcitabine

combined with azenosertib

Group Type EXPERIMENTAL

ZN-c3

Intervention Type DRUG

Investigational drug

Gemcitabine

Intervention Type DRUG

Gemcitabine is an approved drug

Combination with bevacizumab

combined with azenosertib

Group Type EXPERIMENTAL

ZN-c3

Intervention Type DRUG

Investigational drug

Bevacizumab

Intervention Type BIOLOGICAL

Combined with azenosertib

Interventions

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ZN-c3

Investigational drug

Intervention Type DRUG

Carboplatin

Carboplatin is an approved drug

Intervention Type DRUG

Pegylated liposomal doxorubicin

Pegylated liposomal doxorubicin (PLD) is an approved drug

Intervention Type DRUG

Paclitaxel

Paclitaxel is an approved drug

Intervention Type DRUG

Gemcitabine

Gemcitabine is an approved drug

Intervention Type DRUG

Bevacizumab

Combined with azenosertib

Intervention Type BIOLOGICAL

Other Intervention Names

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Study drug Azenosertib

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 0264

Aurora, Colorado, United States

Site Status RECRUITING

Site 0104

Boston, Massachusetts, United States

Site Status RECRUITING

Site 0111

St Louis, Missouri, United States

Site Status RECRUITING

Site 0173

New York, New York, United States

Site Status RECRUITING

Site 0259

Durham, North Carolina, United States

Site Status RECRUITING

Site 0191

Providence, Rhode Island, United States

Site Status RECRUITING

Site 0196

Nashville, Tennessee, United States

Site Status COMPLETED

Site 0103

Houston, Texas, United States

Site Status RECRUITING

Site 2707

South Brisbane, Queensland, Australia

Site Status RECRUITING

Site 2708

Sunshine Coast, Queensland, Australia

Site Status RECRUITING

Site 2709

Adelaide, South Australia, Australia

Site Status ACTIVE_NOT_RECRUITING

Site 2716

Melbourne, Victoria, Australia

Site Status RECRUITING

Site 2706

Melbourne, Victoria, Australia

Site Status RECRUITING

Site 2705

Nedlands, Western Australia, Australia

Site Status RECRUITING

Site 1001

Banja Luka, , Bosnia and Herzegovina

Site Status COMPLETED

Site 1002

Sarajevo, , Bosnia and Herzegovina

Site Status COMPLETED

Site 1003

Tuzla, , Bosnia and Herzegovina

Site Status COMPLETED

Site 1202

Panagyurishte, , Bulgaria

Site Status COMPLETED

Site 1201

Sofia, , Bulgaria

Site Status COMPLETED

Site 1401

Tbilisi, , Georgia

Site Status ACTIVE_NOT_RECRUITING

Site 1902

Belgrade, , Serbia

Site Status COMPLETED

Site 2901

Busan, , South Korea

Site Status COMPLETED

Site 2903

Seoul, , South Korea

Site Status COMPLETED

Site 2904

Seoul, , South Korea

Site Status COMPLETED

Countries

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United States Australia Bosnia and Herzegovina Bulgaria Georgia Serbia South Korea

Central Contacts

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K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals

Role: CONTACT

8582634333

Other Identifiers

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ZN-c3-002

Identifier Type: -

Identifier Source: org_study_id

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