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A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma

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ClinicalTrials.gov Identifier: NCT04833582
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : February 1, 2023
Sponsor:
Information provided by (Responsible Party):
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Study Description
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Brief Summary:
This is a phase 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: ZN-c3 Drug: Gemcitabine Phase 1 Phase 2

Detailed Description:
This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination ZN-c3 with Gemcitabine Drug: ZN-c3
ZN-c3 is an investigational drug.

Drug: Gemcitabine
Gemcitabine is an approved drug
Other Name: Gemzar


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events. [ Time Frame: Through Cycle 1 (21 days) Phase 1 ]
  2. Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1. [ Time Frame: During phase 2, at 18 weeks ]
    EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.


Secondary Outcome Measures :
  1. Event-free survival (EFS) per RECIST Guideline version 1.1. [ Time Frame: At 12 months ]
    EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death.

  2. Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1. [ Time Frame: At 12 months ]
    OS is defined as the time from date of first dosing until the date of death.

  3. The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities. [ Time Frame: Through completion, approximately 42 months ]
  4. Plasma pharmacokinetics (PK) maximum concentration (Cmax). [ Time Frame: Through completion, approximately 42 months ]
  5. Plasma PK time to maximum concentration (Tmax). [ Time Frame: Through completion, approximately 42 months ]
  6. Area under the plasma concentration versus timepoint curve (AUC last). [ Time Frame: Through completion, approximately 42 months ]
  7. Terminal half-life of the plasma PK concentration. [ Time Frame: Through completion, approximately 42 months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 12 years at the time of informed consent
  • Bodyweight ≥ 40 kg
  • Histologically documented relapsed or metastatic osteosarcoma.
  • Must have measurable disease according to RECIST Guideline version 1.1 criteria.
  • Adequate hematologic and organ function.
  • Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation.
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation)
  • Prior therapy with a WEE1 inhibitor
  • A serious illness or medical condition(s).
  • Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1.
  • Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
  • 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, 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 or Torsades de Pointes (TdP).
  • Taking medications with a known risk of TdP.
  • Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.
Contacts and Locations
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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): NCT04833582


Contacts
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Contact: Project Director (858) 263-4333 medicalaffairs@zentalis.com

Locations
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United States, California
Site 0106 Recruiting
Los Angeles, California, United States, 90095
Site 0124 Not yet recruiting
Oakland, California, United States, 94609
Site 0195 Recruiting
Santa Monica, California, United States, 90403
United States, New York
Site 0105 Recruiting
New York, New York, United States, 10065
United States, Ohio
Site 0107 Recruiting
Cincinnati, Ohio, United States, 45229
United States, Oregon
Site 0123 Not yet recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Site 0193 Not yet recruiting
Memphis, Tennessee, United States, 38105
Site 0197 Not yet recruiting
Nashville, Tennessee, United States, 37332
United States, Texas
Site 0103 Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Site 0188 Recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Site 0122 Recruiting
Seattle, Washington, United States, 98195
France
Site 3604 Recruiting
Bordeaux, France, 33000
Site 3601 Not yet recruiting
Lyon, France, 69008
Site 3602 Not yet recruiting
Marseille, France, 13385
Site 3606 Not yet recruiting
Paris, France, 75248
Site 3605 Recruiting
Toulouse, France, 31100
Sponsors and Collaborators
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
More Information
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Responsible Party: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04833582    
Other Study ID Numbers: ZN-c3-003
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Gemcitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs