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A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04814108
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
K-Group Beta

Tracking Information
First Submitted Date  ICMJE March 18, 2021
First Posted Date  ICMJE March 24, 2021
Last Update Posted Date February 25, 2022
Actual Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
Official Title  ICMJE 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
Brief Summary This is a Phase 2 study to evaluate the clinical activity, safety, pharmacokinetics (PK), and related biomarkers of ZN-c3 in adult women with recurrent or persistent uterine serous carcinoma (USC).
Detailed Description This is a Phase 2 open-label, multicenter study to evaluate the clinical activity, safety, pharmacokinetics (PK), and related biomarkers of ZN-c3 in adult women with recurrent or persistent uterine serous carcinoma (USC).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Serous Carcinoma
Intervention  ICMJE Drug: ZN-c3
ZN-c3 is an investigational drug.
Study Arms  ICMJE Experimental: ZN-c3 Single Agent
Intervention: Drug: ZN-c3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2021)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Project Director (858) 263-4333 info@zenopharma.com
Listed Location Countries  ICMJE Australia,   Canada,   Georgia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04814108
Other Study ID Numbers  ICMJE ZN-c3-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party K-Group Beta
Original Responsible Party Same as current
Current Study Sponsor  ICMJE K-Group Beta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account K-Group Beta
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP