A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
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|ClinicalTrials.gov Identifier: NCT04814108|
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : February 25, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Uterine Serous Carcinoma||Drug: ZN-c3||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2023|
|Experimental: ZN-c3 Single Agent||
ZN-c3 is an investigational drug.
- To investigate the antitumor activity of ZN-c3 based on the objective response rate (ORR). [ Time Frame: 2 years ]Objective response rate (ORR) as defined by the revised Response Evaluation Criteria in Solid Tumors RECIST Guideline version 1.1
- To investigate the antitumor clinical activity based on Duration of Response (DOR) [ Time Frame: 2 years ]Duration of Response (DOR) as defined by the revised RECIST Guideline version 1.1
- To investigate the antitumor clinical activity based on Progression-Free Survival (PFS) [ Time Frame: 2 years ]Progression- free survival (PFS) as defined by the revised RECIST Guideline version 1.1
- To investigate the safety and tolerability of ZN-c3 [ Time Frame: 2 years ]Frequency and severity of AEs, including laboratory abnormalities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- Females age ≥18 years of age at the time of informed consent.
- Recurrent or persistent USC.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Measurable disease, defined as at least one lesion that can be accurately measured per revised Response Evaluation Criteria in Solid Tumors RECIST Guideline version 1.1 criteria.
- Adequate hematologic and organ function.
- Females of childbearing potential must agree to use an effective method of contraception per institutional standard prior to the first dose and for 90 days after the last dose of ZN c3.
- Prior treatment with a cell cycle checkpoint inhibitor.
- Prior therapy with ZN-c3 or any other WEE1 inhibitor.
- A serious illness or medical condition(s).
- Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding ≤Grade 2 neuropathy, alopecia, or skin pigmentation).
- Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 28 days prior to C1D1.
- Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
- 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of > 480 ms at screening, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
- History or current evidence of congenital or family history of long QT syndrome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814108
|Contact: Project Director||(858) email@example.com|
|Responsible Party:||K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc|
|Other Study ID Numbers:||
|First Posted:||March 24, 2021 Key Record Dates|
|Last Update Posted:||February 25, 2022|
|Last Verified:||February 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous