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Anti-metabolites

ZN-c3 + Gemcitabine for Osteosarcoma

Q: How is ZN-c3 commonly employed in medical care?

<p>ZN-c3 is commonly used to treat <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, along with other malignancies such as head and neck carcinoma, advanced pancreatic adenocarcinomas and cervical cancers.</p>

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 through completion, approximately 42 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion, approximately 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion, approximately 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion, approximately 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.

Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.

Secondary outcome measures

Area under the plasma concentration versus timepoint curve (AUC last).

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.

+4 more

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

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

K-Group BetaLead Sponsor

5 Previous Clinical Trials

644 Total Patients Enrolled

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor

7 Previous Clinical Trials

760 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this clinical investigation?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial began recruiting patients on August 1st 2021 and is still ongoing as of August 9th 2022. A total of 84 individuals need to be enrolled from 12 different locations across America."

Answered by AI

What is the enrollment criterion for this medical experiment?

"Affirmative. The details hosted on clinicaltrials.gov state that recruitment for this medical trial is ongoing, with the original posting date being August 1st 2021 and most recent updates occurring in August 2022. 84 individuals are needed across 12 distinct sites for study participation."

Answered by AI

In what areas is this research trial being conducted?

"This trial uses a network of 12 different medical centres, including Site 0103 in Houston, Site 0105 in New york, and Site 0197 in Nashville."

Answered by AI

What are the other research efforts that have been conducted with ZN-c3?

"Currently, there are 446 ongoing ZN-c3 trials with 134 in their terminal phase. The majority of the studies related to this drug are based in Woolloongabba, Queensland; however, a wide range of medical centres across 24565 locations have opened up clinical trials for ZN-c3."

Answered by AI

How is ZN-c3 commonly employed in medical care?

"ZN-c3 is commonly used to treat small cell lung cancer, along with other malignancies such as head and neck carcinoma, advanced pancreatic adenocarcinomas and cervical cancers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04833582.

All > Osteosarcoma