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CDK4/6 Inhibitor

Ribociclib + Topotecan + Temozolomide for Neuroblastoma

Phase 1 & 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 12 months and ≤ 21 years at the time of signing consent form
Sexually active males (including those that have had a vasectomy), who do not agree to abstinence, must be willing to use a condom during intercourse while on study treatment and for 6 months after stopping treatment
Must not have
Received prior treatment with a CDK4/6 inhibitor
Allogeneic stem cell transplant within 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

This trial tests a cancer drug combo on kids with neuroblastoma, medulloblastoma, glioma, rhabdoid tumors, and rhabdomyosarcoma.

Who is the study for?
This trial is for children and young adults aged 12 months to 21 years with certain types of solid tumors, including neuroblastoma, that have not responded to standard treatments. Participants need a life expectancy over 12 weeks, must understand the study and consent to it, have adequate organ function, and agree to use effective contraception if applicable.
What is being tested?
The trial is testing the combination of Ribociclib with Topotecan and Temozolomide (TOTEM) in pediatric patients. It aims to find out how safe this mix is and how well it works against relapsed or refractory neuroblastoma and other solid tumors in kids.
What are the potential side effects?
Possible side effects include reactions related to the immune system's response, fatigue, digestive issues like nausea or constipation, blood cell count changes which can increase infection risk or cause anemia. There may also be specific effects from each drug such as liver problems from Ribociclib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 and 21 years old.
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I agree to use a condom during sex while on the study and for 6 months after.
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My cancer is one of the listed types and has not responded to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a CDK4/6 inhibitor before.
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I had a stem cell transplant from a donor within the last 3 months.
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I had a stem cell transplant for my cancer less than 8 weeks ago.
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I finished my last radiation treatment less than 4 weeks ago.
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I don't have severe health issues that could affect my treatment.
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I am allergic to ingredients in ribociclib, topotecan, or temozolomide.
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I have a history of QTc prolongation or take medication that affects my heart's rhythm.
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I do not have uncontrolled heart issues or abnormal heart rhythms.
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I have not received any live vaccines in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 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
Phase 1- Part A: Percentage of participants with Dose Limiting Toxicities (DLTs) in Cycle 1
Phase I- Part B: Overall response rate (ORR) as assessed by Blinded Independent Review Committee (BIRC)
Phase II- ORR as assessed by BIRC
Secondary study objectives
Area under the plasma concentration-time curve (AUC) of ribociclib (Phase I-Part A, Phase I-Part B, Phase II)
Change from baseline in Pediatric Quality of Life Inventory (PedsQL) questionnaire (Phase II)
Clinical benefit rate (CBR) as assessed by BIRC (Phase II)
+12 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase II- Ribociclib+Topotecan and TemozolomideExperimental Treatment3 Interventions
Participants with r/r NB will be treated with ribocilib in combination with topotecan and temozolomide at the RP2D defined from Phase I part A.
Group II: Phase I-part A: Ribociclib + Topotecan and TemozolomideExperimental Treatment3 Interventions
Participants with r/r NB, MB, HGG, MRT or RMS will be treated with ribociclib in combination with topotecan and temozolomide to determine MTD and/or RP2D. Ribociclib dose will be escalated with topotecan and temozolomide.
Group III: Phase I-Part B: r/r MRT CohortExperimental Treatment3 Interventions
Participants with r/r MRT will be treated with ribociclib in combination with topotecan and temozolomide at the PR2D identified from Phase I-Part A
Group IV: Phase I-Part B: r/r HGG CohortExperimental Treatment3 Interventions
Participants with r/r HGG will be treated with ribociclib in combination with topotecan and temozolomide at the PR2D identified from Phase I-Part A
Group V: Phase I- Part B: r/r RMS CohortExperimental Treatment3 Interventions
Participants with r/r RMS will be treated with ribociclib in combination with topotecan and temozolomide at the PR2D identified from Phase I-Part A
Group VI: Phase I- Part B: r/r NB CohortExperimental Treatment3 Interventions
Participants with r/r NB will be treated with ribociclib in combination with topotecan and temozolomide at the PR2D identified from Phase I-Part A
Group VII: Phase I- Part B: r/r MB CohortExperimental Treatment3 Interventions
Participants with r/r MB will be treated with ribociclib in combination with topotecan and temozolomide at the PR2D identified from Phase I-Part A
Group VIII: Phase II: Placebo+Topotecan and TemozolomidePlacebo Group3 Interventions
Participants with r/r NB will be treated ribociclib matching placebo in combination with topotecan and temozolomide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
FDA approved
Temozolomide
FDA approved
Ribociclib
FDA approved

Find a Location

Who is running the clinical trial?

Innovative Therapies For Children with Cancer ConsortiumOTHER
13 Previous Clinical Trials
1,865 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,472 Total Patients Enrolled
5 Trials studying Neuroblastoma
272 Patients Enrolled for Neuroblastoma

Media Library

Ribociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05429502 — Phase 1 & 2
Neuroblastoma Research Study Groups: Phase II: Placebo+Topotecan and Temozolomide, Phase II- Ribociclib+Topotecan and Temozolomide, Phase I-part A: Ribociclib + Topotecan and Temozolomide, Phase I- Part B: r/r NB Cohort, Phase I- Part B: r/r MB Cohort, Phase I-Part B: r/r HGG Cohort, Phase I-Part B: r/r MRT Cohort, Phase I- Part B: r/r RMS Cohort
Neuroblastoma Clinical Trial 2023: Ribociclib Highlights & Side Effects. Trial Name: NCT05429502 — Phase 1 & 2
Ribociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05429502 — Phase 1 & 2
~154 spots leftby Feb 2029
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