A Study of ZN-c3 in Patients With Ovarian Cancer

NCT04516447 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ZN-c3-002
• Study Type: interventional
• Target: 140
• Locations: 7 countries
• Sites: 24

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.

Conditions

Solid Tumor; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab

  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

  Through completion, approximately 40 months

• To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine

  Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1

  Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, gemcitabine, or bevacizumab)

Study Arms (5)

Combination with carboplatin

EXPERIMENTAL

combined with azenosertib

Drug: ZN-c3; Drug: Carboplatin

Combination with PLD

EXPERIMENTAL

combined with azenosertib

Drug: ZN-c3; Drug: Pegylated liposomal doxorubicin

Combination with paclitaxel

EXPERIMENTAL

combined with azenosertib

Drug: ZN-c3; Drug: Paclitaxel

Combination with gemcitabine

EXPERIMENTAL

combined with azenosertib

Drug: ZN-c3; Drug: Gemcitabine

Combination with bevacizumab

EXPERIMENTAL

combined with azenosertib

Drug: ZN-c3; Biological: Bevacizumab

Interventions

ZN-c3 DRUG

Investigational drug

Also known as: Study drug, Azenosertib

Combination with PLD; Combination with bevacizumab; Combination with carboplatin; Combination with gemcitabine; Combination with paclitaxel

Carboplatin DRUG

Carboplatin is an approved drug

Combination with carboplatin

Pegylated liposomal doxorubicin DRUG

Pegylated liposomal doxorubicin (PLD) is an approved drug

Combination with PLD

Paclitaxel DRUG

Paclitaxel is an approved drug

Combination with paclitaxel

Gemcitabine DRUG

Gemcitabine is an approved drug

Combination with gemcitabine

Bevacizumab BIOLOGICAL

Combined with azenosertib

Combination with bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.
• 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.
• Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert's disease.
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.

You may not qualify if:

• 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:
• Major surgery within 28 days.
• Radiation therapy within 21 days.
• Autologous or allogeneic stem cell transplant within 3 months.
• A serious illness or medical condition(s) including, but not limited to, the following:
• Brain metastases that require immediate treatment or are clinically or radiographically unstable.
• Myocardial impairment of any cause.
• Significant gastrointestinal abnormalities.
• Active or uncontrolled infection.
• 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.

Sponsors & Collaborators

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

Study Sites (24)

Site 0264

Aurora, Colorado, 80045, United States

RECRUITING

Site 0104

Boston, Massachusetts, 02215, United States

RECRUITING

Site 0111

St Louis, Missouri, 53110, United States

RECRUITING

Site 0173

New York, New York, 10029, United States

RECRUITING

Site 0259

Durham, North Carolina, 27710, United States

RECRUITING

Site 0191

Providence, Rhode Island, 02905, United States

RECRUITING

Site 0196

Nashville, Tennessee, 37203, United States

COMPLETED

Site 0103

Houston, Texas, 77030, United States

RECRUITING

Site 2707

South Brisbane, Queensland, 4101, Australia

RECRUITING

Site 2708

Sunshine Coast, Queensland, 4556, Australia

RECRUITING

Site 2709

Adelaide, South Australia, 5000, Australia

ACTIVE NOT RECRUITING

Site 2716

Melbourne, Victoria, 3121, Australia

RECRUITING

Site 2706

Melbourne, Victoria, 3144, Australia

RECRUITING

Site 2705

Nedlands, Western Australia, 6009, Australia

RECRUITING

Site 1001

Banja Luka, 78000, Bosnia and Herzegovina

COMPLETED

Site 1002

Sarajevo, 71000, Bosnia and Herzegovina

COMPLETED

Site 1003

Tuzla, 75000, Bosnia and Herzegovina

COMPLETED

Site 1202

Panagyurishte, 4500, Bulgaria

COMPLETED

Site 1201

Sofia, 1632, Bulgaria

COMPLETED

Site 1401

Tbilisi, 0112, Georgia

ACTIVE NOT RECRUITING

Site 1902

Belgrade, 11080, Serbia

COMPLETED

Site 2901

Busan, South Korea

COMPLETED

Site 2903

Seoul, 03080, South Korea

COMPLETED

Site 2904

Seoul, 05505, South Korea

COMPLETED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Drug Evaluation; Carboplatin; liposomal doxorubicin; Paclitaxel; Gemcitabine; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

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

CONTACT

8582634333; medicalaffairs@zentalis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 18, 2020
• Study Start: October 26, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): February 28, 2027
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); BU (2); BO (3); US (8); GE (1); SE (1); KR (3)