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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 months

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

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

Primary outcome measures

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 outcome measures

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

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase II- Ribociclib+TOTEMExperimental Treatment3 Interventions

Participants with r/r NB will be treated with ribocilib in combination with TOTEM at the RP2D defined from Phase I part A.

Group II: Phase I-part A: Ribociclib+TOTEMExperimental Treatment3 Interventions

Participants with r/r NB, MB, HGG, MRT or RMS will be treated with ribociclib in combination with TOTEM to determine MTD and/or RP2D. Ribociclib dose will be scalated while topotecan and temozolomide will be administered at a fixed dose.

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 TOTEM 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 TOTEM 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 TOTEM 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 TOTEM 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 TOTEM at the PR2D identified from Phase I-Part A

Group VIII: Phase II: Placebo+TOTEMPlacebo Group3 Interventions

Participants with r/r NB will be treated ribociclib matching placebo in combination with TOTEM

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topotecan

FDA approved

Temozolomide

FDA approved

Ribociclib

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Innovative Therapies For Children with Cancer ConsortiumOTHER

12 Previous Clinical Trials

1,867 Total Patients Enrolled

Novartis PharmaceuticalsLead Sponsor

2,856 Previous Clinical Trials

4,197,474 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 I-part A: Ribociclib+TOTEM, 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, Phase II- Ribociclib+TOTEM, Phase II: Placebo+TOTEM

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

Frequently Asked Questions

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

Does this research have any current openings for participants?

"Affirmative. According to clinicaltrials.gov, the trial was first made available on December 27th 2022 and has been recently updated as of May 4th 2023. Currently 231 participants are needed from 5 distinct medical centres across the country."

Answered by AI

Is this clinical trial open to participants over the age of 35?

"As specified in the criteria for inclusion, eligible participants must fall within a window of 12 months and 21 years old. There are 159 trials that accommodate minors under 18, as well as 42 studies designed to support seniors aged 65 or older."

Answered by AI

What is the size of the participant cohort for this trial?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which was initially published on December 27th 2022, is actively recruiting participants. 231 patients need to be recruited across 5 locations."

Answered by AI

In what areas can patients find access to this clinical trial?

"At present, this medical trial is recruiting from 5 distinct sites. These facilities are located in Villejuif Cedex, Barcelona and Koeln as well as other cities around the world. To reduce your travel burden if you decide to participate, it's recommended that you select a site near you."

Answered by AI

What is the primary purpose of this research project?

"The main purpose of this clinical trial, that will be monitored for a maximum period of 12 months is to gauge the percentage of participants with Dose Limiting Toxicities (DLTs) in Cycle 1. Other objectives include estimating Clinical benefit rate (CBR), as assessed by BIRC (Phase II). This metric is defined as the portion of patients who responded positively to treatment and maintained stable disease over 24 weeks. Additionally, PK blood samples will be collected at selected time-points during Phase I-Part A, Part B and Phase II to measure Area under the plasma concentration-time curve (AUC) and Maximum plasma concentration(C"

Answered by AI

Is there an opportunity to participate in this experiment?

"This clinical trial is recruiting 231 participants aged between 12 months and 21 years old with neuroblastoma. To qualify for the study, individuals must meet a series of criteria including: having the capacity to understand written informed consent documents; measurable disease as per International Neuroblastoma Response Criteria; available MYCN status before screening; various histologically or cytologicly confirmed solid tumors such as medulloblastoma, high-grade gliomas, malignant rhabdoid tumours, and rhabdomyosarcoma dependent upon subtype and fusion status; given certain ages must also have Lansky Play Score ≥ 50%;"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

2022. "Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429502.

All > Neuroblastoma > Medulloblastoma