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Anti-metabolites

ZN-c3 + Gemcitabine for Osteosarcoma

Phase 1 & 2
Waitlist Available
Research Sponsored by K-Group Beta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug combination to treat osteosarcoma, a bone cancer.

Who is the study for?
This trial is for adults and kids over 12 with osteosarcoma that's come back or spread, who can measure their cancer using RECIST 1.1, have good blood and organ function, weigh at least 40 kg, and will use birth control. It's not for those with certain heart conditions, pregnant or breastfeeding women, people taking specific drugs affecting the body's drug processing system or those with other serious illnesses.
What is being tested?
The study tests ZN-c3 combined with gemcitabine in patients whose osteosarcoma has either returned after treatment or hasn't responded to previous treatments. This phase 1/2 trial aims to find out how safe this combination is and how well it works against this type of bone cancer.
What are the potential side effects?
Possible side effects include reactions related to the immune system since both ZN-c3 and Gemcitabine can affect how your body fights disease. There might also be typical chemotherapy-related side effects like nausea, fatigue, low blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.
Secondary study objectives
Event-free survival (EFS) per RECIST Guideline version 1.1.
Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination ZN-c3 with GemcitabineExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

K-Group BetaLead Sponsor
5 Previous Clinical Trials
581 Total Patients Enrolled
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
697 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04833582 — Phase 1 & 2
Osteosarcoma Research Study Groups: Combination ZN-c3 with Gemcitabine
Osteosarcoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04833582 — Phase 1 & 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04833582 — Phase 1 & 2
~19 spots leftby Dec 2025
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