A Study of ZN-c3 in Patients With Ovarian Cancer

Last updated: November 22, 2024
Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Overall Status: Active - Recruiting

Phase

1

Condition

Fallopian Tube Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

Pegylated liposomal doxorubicin

Bevacizumab

Carboplatin

Clinical Study ID

NCT04516447
ZN-c3-002
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed high-grade serous epithelial ovariancarcinoma, fallopian tube, or peritoneal carcinoma.

  • Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy inthe 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 dailyadministration of filgrastim/sargramostim or within 3 weeks afteradministration of pegfilgrastim.

  2. Platelet count ≥ 100 × 10^9/L; excluding measurements obtained within 3 daysafter transfusion of platelets or within 3 weeks after administration ofplatelet growth factors.

  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upperlimit of normal (ULN). If liver function abnormalities are due to underlyingliver metastases, AST and ALT ≤ 5 x ULN.

  4. Total serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN in the case of Gilbert'sdisease.

  5. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 60 mL/min.

Exclusion

Exclusion Criteria:

  • Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderlineovarian tumor.

  • Any of the following treatment interventions within the specified time frame priorto 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 orradiographically 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 oncomputed tomography (CT) scan, recent hospitalization for small bowel obstructionwithin 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesiswithin 6 weeks prior to Cycle 1 Day 1.

  • Subjects with active (uncontrolled, metastatic) second malignancies orrequiring therapy.

Study Design

Total Participants: 140
Treatment Group(s): 6
Primary Treatment: Pegylated liposomal doxorubicin
Phase: 1
Study Start date:
October 26, 2020
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Clinical Site 10

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Site 2707

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Site 2708

    Sunshine Coast, Queensland 4556
    Australia

    Active - Recruiting

  • Site 2709

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Site 2706

    Melbourne, Victoria 3144
    Australia

    Active - Recruiting

  • Site 2716

    Melbourne, Victoria 3121
    Australia

    Active - Recruiting

  • Site 2705

    Nedlands, Western Australia 6009
    Australia

    Active - 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

    Site Not Available

  • Site 2901

    Busan,
    Korea, Republic of

    Completed

  • Site 2903

    Seoul, 03080
    Korea, Republic of

    Completed

  • Site 2904

    Seoul, 05505
    Korea, Republic of

    Completed

  • Site 1902

    Belgrade, 11080
    Serbia

    Completed

  • Site 0264

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Site 0104

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Site 0111

    Saint Louis, Missouri 53110
    United States

    Active - Recruiting

  • Site 0173

    New York, New York 10029
    United States

    Active - Recruiting

  • Site 0259

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Site 0191

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Site 0196

    Nashville, Tennessee 37203
    United States

    Completed

  • Site 0103

    Houston, Texas 77030
    United States

    Active - Recruiting

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