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MDM2 Inhibitor
Idasanutlin + Selinexor for Brain Cancer
Phase 1
Waitlist Available
Led By Amar Gajjar, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 7 years from start of treatment
Awards & highlights
Study Summary
This trial tests a combination of two drugs to find the safest and most effective dose for children with rare brain tumors.
Who is the study for?
This trial is for children and young adults aged 6 months to 25 years with specific brain or extra-CNS malignant rhabdoid tumors that have worsened or returned after treatment. Participants must be recovered from previous therapies, not have certain infections or uncontrolled diseases, agree to use effective contraception if applicable, and cannot be pregnant.Check my eligibility
What is being tested?
The iSTAR study tests the combination of two oral drugs, selinexor (an XPO1 inhibitor) and idasanutlin (an MDM2 inhibitor), in patients with AT/RT or MRT. The goal is to find the safest dose for future studies and see how well these drugs work together against these aggressive tumors.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with cancer treatments like selinexor and idasanutlin may include nausea, vomiting, diarrhea, fatigue, blood count changes leading to increased infection risk, liver issues, and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 7 years from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7 years from start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Idasanutlin area under the plasma concentration time curve (AUC) in children with recurrent or progressive AT/RT or MRT
Idasanutlin plasma apparent systemic clearance (CL/F) in children with recurrent or progressive AT/RT or MRT
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of combination treatment with oral idasanutlin and selinexor in children with recurrent or progressive AT/RT or MRT in the dose finding/safety phase.
Secondary outcome measures
Objective response rate in subjects with progressive/relapsed AT/RT
Objective response rate in subjects with progressive/relapsed MRT
Overall survival in subjects with progressive/ relapsed MRT
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Expansion Phase: Stratum CExperimental Treatment2 Interventions
Patients with progressive/relapsed, synchronous/metachronous AT/RT & MRT
Group II: Expansion Phase: Stratum BExperimental Treatment2 Interventions
Patients with progressive/relapsed MRT
Group III: Expansion Phase: Stratum AExperimental Treatment2 Interventions
Patients with progressive/relapsed AT/RT
Group IV: Dose Finding/Safety PhaseExperimental Treatment2 Interventions
Patients with progressive/relapsed atypical teratoid/rhabdoid tumors (AT/RT) & malignant rhabdoid tumors (MRT) or synchronous/metachronous AT/RT &MRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Idasanutlin
2018
Completed Phase 2
~380
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,613 Total Patients Enrolled
9 Trials studying Rhabdoid Tumor
4,360 Patients Enrolled for Rhabdoid Tumor
Amar Gajjar, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
9 Previous Clinical Trials
2,589 Total Patients Enrolled
3 Trials studying Rhabdoid Tumor
1,041 Patients Enrolled for Rhabdoid Tumor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent tests show my organs are functioning well.I agree to not have unprotected sex or donate sperm.I experience severe nausea, vomiting, or diarrhea that treatment hasn't helped, or I've had a significant part of my small intestine removed.My child has a relapsed rhabdoid tumor and has tried at least one treatment beyond surgery.I have taken a pregnancy test in the last week and it was negative.I am not currently on any other cancer treatments.I am between 6 months and 25 years old.I can take pills by mouth or have a tube (NG or G-tube) for medication.I've had a stem cell transplant within the last 30 or 100 days.I haven't had major surgery in the last 21 days and don't expect to need one during the study.My tumor sample from diagnosis or relapse is available, or I can provide molecular data from previous tests.I have never been treated with MDM2 and XPO1 inhibitors together.I don't have severe side effects from treatment, except for hair loss, hearing issues, or numbness.I have a serious heart condition that is not under control.My CNS tumor growth after radiation was confirmed as not real by a biopsy.I am physically active and can care for myself.I do not have an uncontrolled infection or one that poses a risk if I become neutropenic.I have HIV or active hepatitis B/C, or a past infection that's now resolved.I have recovered or will recover from side effects of cancer treatment before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Phase: Stratum B
- Group 2: Dose Finding/Safety Phase
- Group 3: Expansion Phase: Stratum A
- Group 4: Expansion Phase: Stratum C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for this experimental research limited to those above 55 years?
"This clinical trial is welcoming individuals between 6 months and 25 years to participate."
Answered by AI
Does my profile meet the criteria to join this research endeavor?
"Eligibility criteria for this clinical trial requires that patients have a specific type of cancer, rhabdoid tumour, and be aged between 6 months to 25 years. Approximately 40 individuals are being sought after."
Answered by AI
Are individuals currently being recruited for participation in this research?
"According to the info posted on clinicaltrials.gov, this specific trial is no longer actively seeking participants; it was initially made public on August 1st 2023 and last edited July 11th of that same year. Nevertheless, there are currently 2540 other trials willing to take in candidates."
Answered by AI
What safeguards are in place to protect participants during the Dose Finding/Safety Phase?
"With limited evidence of its safety and efficacy, Dose Finding/Safety Phase was judged to be a 1 on our scale from 1-3."
Answered by AI
What goals is this study attempting to accomplish?
"This clinical trial, which will be administered for a duration of 1 month with Idasanutlin and selinexor medications, aims to evaluate the systemic clearance (CL/F) rate in children diagnosed with recurrent or progressive AT/RT or MRT. The secondary objectives include calculating the objective response rate by measuring partial/complete responses from patients with measurable disease; assessing progression-free survival among those suffering from advanced AT/RT; and tracking progression-free survival rates amongst individuals afflicted by relapsed MRT. All outcomes will be reported using 95% confidence intervals as per Kaplan–Meier estimations."
Answered by AI
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