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MDM2 Inhibitor

Navtemadlin + Radiation for Soft Tissue Sarcoma

Phase 1

Waitlist Available

Led By Meng X Welliver

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Study Summary

This trial studies navtemadlin given with radiation therapy before surgery in patients with soft tissue sarcoma to see if it can reduce the size of the tumor.

Who is the study for?

This trial is for adults with intermediate or high-grade soft tissue sarcoma larger than 5 cm, aiming for curative treatment. Participants must have no history of other cancers (with some exceptions), not be pregnant or breastfeeding, and cannot have metastatic disease. They should not have had chemotherapy or radiotherapy for the sarcoma before and must agree to avoid certain medications during the trial.Check my eligibility

What is being tested?

The study tests navtemadlin combined with radiation therapy in patients with soft tissue sarcoma. Navtemadlin blocks enzymes that cancer cells need to grow, while radiation aims to kill tumor cells. The goal is to shrink tumors before surgery.See study design

What are the potential side effects?

Potential side effects include typical reactions from radiation like skin irritation and fatigue, as well as possible effects from navtemadlin such as nausea, vomiting, diarrhea, changes in blood counts leading to increased risk of infections or bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose/recommended phase 2 dosage

Secondary outcome measures

AMG 232 (KRTI-232) exposure-response relationships

Disease free survival

Local failure

+4 more

Other outcome measures

Clinical outcomes by genomic biomarkers

Tumor genetic mutations in deoxyribonucleic acid ribonucleic acid isolated from exosomes

Tumor volume changes

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Step 2, Group II (radiation therapy)Experimental Treatment1 Intervention

Patients undergo radiation therapy daily on weeks 1-5 in the absence of disease progression or unacceptable toxicity.

Group II: Step 2, Group I (navtemadlin, radiation therapy)Experimental Treatment2 Interventions

Patients receive navtemadlin as in Step 1 and undergo radiation therapy daily on weeks 1-5 in the absence of disease progression or unacceptable toxicity.

Group III: Step 1 (tumor tissue testing, navtemadlin)Experimental Treatment2 Interventions

Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on day 2, days 2 and 4, days 2-4, days 2-5, or days 1-5 of weeks 1 to 5 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,115 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,814 Total Patients Enrolled

Meng X WelliverPrincipal InvestigatorNRG Oncology

Media Library

Soft Tissue Sarcoma Research Study Groups: Step 1 (tumor tissue testing, navtemadlin), Step 2, Group I (navtemadlin, radiation therapy), Step 2, Group II (radiation therapy)

Frequently Asked Questions

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

In how many sites is this clinical experiment being conducted?

"This trial has 37 recruiting sites, with notable locations being UPMC-Shadyside Hospital in Pittsburgh, Parkland Memorial Hospital in Dallas, and Aurora Health Center-Fond du Lac in Fond Du Lac. There are also 34 other enrolment centers scattered across the nation."

Answered by AI

How many individuals are involved in this research endeavor?

"Currently, recruitment for this trial has been halted. It was initially published on 3rd November 2017 and amended lastly on 8th September 2022. If you are looking to participate in similar studies, there are 443 trials open for enrolment involving resectable soft tissue sarcoma patients and 13 clinical experiments searching for MDM2 Inhibitor KRT-232 volunteers at the moment."

Answered by AI

Does this experiment still have room for new participants?

"This clinical trial is now closed to new participants; it was initially posted on the 11th of March 2017 and its information last edited on September 8th 2022. Patients looking for other treatments should be aware there are currently 443 trials recruiting those who have resectable soft tissue sarcoma and 13 studies enrolling patients that need MDM2 Inhibitor KRT-232."

Answered by AI

To what degree is KRT-232 MDM2 Inhibitor a secure drug for patients?

"Currently, the safety of MDM2 Inhibitor KRT-232 stands at a score of 1 due to its limited Phase One trial data. However, as more information is gathered about its efficacy and safety profile it may be subject to reevaluation."

Answered by AI

What empirical evidence has been collected in regards to the efficacy of KRT-232 as an MDM2 Inhibitor?

"Currently, KRT-232's MDM2 Inhibitor is being trialled in 13 active studies with one of them at the Phase 3 level. These medical trials are primarily taking place near Katowice and New york City; however, there are 582 other sites running clinical research on this drug."

Answered by AI

Recent research and studies

Pediatric Blood & CancerJournal

Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges

Vatner, Ralph, Charles D. James, Vythialingam Sathiaseelan, Kathryn M. Bondra, John A. Kalapurakal, and Peter J. Houghton. 2020. “Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.28439.

Pediatric Blood & CancerJournal

Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges

Molecular OncologyJournal

DNA in Extracellular Vesicles: Biological and Clinical Aspects

Elzanowska, Julia, Christine Semira, and Bruno Costa‐Silva. 2020. “DNA in Extracellular Vesicles: Biological and Clinical Aspects”. Molecular Oncology. Wiley. doi:10.1002/1878-0261.12777.

clinicaltrials.govStudy

Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma