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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04516447
Other study ID # ZN-c3-002
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 26, 2020
Est. completion date February 28, 2027

Study information

Verified date May 2024
Source K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Contact K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
Phone 8582634333
Email medicalaffairs@zentalis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date February 28, 2027
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
ZN-c3
Investigational drug
Carboplatin
Carboplatin is an approved drug
Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin (PLD) is an approved drug
Paclitaxel
Paclitaxel is an approved drug
Gemcitabine
Gemcitabine is an approved drug
Biological:
Bevacizumab
Combined with azenosertib

Locations

Country Name City State
Australia Site 2709 Adelaide South Australia
Australia Site 2706 Melbourne Victoria
Australia Site 2705 Nedlands Western Australia
Australia Site 2707 South Brisbane Queensland
Australia Site 2708 Sunshine Coast Queensland
Bosnia and Herzegovina Site 1001 Banja Luka
Bosnia and Herzegovina Site 1002 Sarajevo
Bosnia and Herzegovina Site 1003 Tuzla
Bulgaria Site 1202 Panagyurishte
Bulgaria Site 1201 Sofia
Georgia Site 1401 Tbilisi
Korea, Republic of Site 2901 Busan
Korea, Republic of Site 2903 Seoul
Korea, Republic of Site 2904 Seoul
Serbia Site 1902 Belgrade
United States Site 0264 Aurora Colorado
United States Site 0104 Boston Massachusetts
United States Site 0259 Durham North Carolina
United States Site 0103 Houston Texas
United States Site 0196 Nashville Tennessee
United States Site 0173 New York New York
United States Site 0191 Providence Rhode Island
United States Site 0111 Saint Louis Missouri

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina,  Bulgaria,  Georgia,  Korea, Republic of,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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)
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