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Targeted Therapy

Labs for Neuroblastoma (NEPENTHE Trial)

Phase 1
Waitlist Available
Led By Yael P Mossé, MD
Research Sponsored by Yael P Mosse
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged ≥1 years to ≤ 21 years
Relapsed or refractory neuroblastoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

NEPENTHE Trial Summary

This trial is testing personalized cancer treatment based on a patient's individual tumor genomic changes.

Eligible Conditions
  • Neuroblastoma
  • Cancer

NEPENTHE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

NEPENTHE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Area under the curve from time zero to last quantifiable concentration
Incidence of dose limiting toxicities when combining ceritinib with ribociclib
Percentage of patients with overall objective response
Secondary outcome measures
Cataloguing of genomic alterations identified from biopsies performed at time of relapse in patients with relapsed or refractory neuroblastoma

NEPENTHE Trial Design

2Treatment groups
Experimental Treatment
Group I: Molecular AnalysisExperimental Treatment7 Interventions
All participants with relapsed or refractory neuroblastoma will have a tumor biopsy to identify genetic mutations. There is no drug given in this arm of the trial.
Group II: Group 1: ALKExperimental Treatment11 Interventions
Qualified participants whose tumors show certain mutations in the anaplastic lymphoma kinase (ALK) pathway (based on genetic sequencing results) will receive a combination therapy of ceritinib and ribociclib, to be administered orally in 28-day cycles. Two different doses of ceritinib and three different doses of ribociclib will be evaluated. Once the investigators have identified the highest safe dose of both drugs that can be given at the same time, additional participants will be enrolled in the study at this dose level. It is possible that if starting at a lower dose, participants may take a higher dose once that dose has been deemed safe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceritinib
FDA approved
Interviews
2017
N/A
~3890
Ribociclib
FDA approved
Biopsy
2014
Completed Phase 4
~840
Next Generation Sequencing
2018
N/A
~260

Find a Location

Who is running the clinical trial?

Yael P MosseLead Sponsor
Novartis PharmaceuticalsIndustry Sponsor
2,851 Previous Clinical Trials
4,197,514 Total Patients Enrolled
5 Trials studying Neuroblastoma
437 Patients Enrolled for Neuroblastoma
Foundation MedicineIndustry Sponsor
32 Previous Clinical Trials
16,126 Total Patients Enrolled

Frequently Asked Questions

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

Is this endeavor an unprecedented effort?

"Labs has been the subject of clinical trials since 2012, when it was first endorsed by pharmaceutical giant Pfizer. Following its initial study involving 189 individuals, Labs received approval for Phase 1 and 2 drug testing. Currently, 58 ongoing studies are taking place throughout 786 cities in 49 countries worldwide."

Answered by AI

What is the upper limit of people included in this clinical endeavor?

"Affirmative. Clinicaltrials.gov data reveals that the trial, which was initially announced on July 1st 2016, is currently enrolling participants. This clinical study seeks 131 patients from 2 medical centres."

Answered by AI

Is the age range for this study inclusive of individuals over 35 years old?

"According to the stated requirements, individuals between the ages of one year old and twenty-one years old are eligible for enrollment in this clinical trial."

Answered by AI

What are the primary purposes of utilizing Labs?

"Labs is the most popular treatment for breast cancer, but it can also be used to manage a variety of other medical issues including malignant neoplasms, non-small cell lung carcinoma, and postmenopause."

Answered by AI

Is there still an availability for willing participants in this research project?

"Correct. According to clinicaltrials.gov, the trial is actively recruiting participants; initial posting was on July 1st 2016 and latest update occurred on August 2nd 2022. 131 patients are required from two medical centres for this research study."

Answered by AI

How do I sign up to participate in this research?

"This medical trial is enrolling 131 paediatric patients from 1 year to 21 years old who are fighting malignancies. To be eligible, participants need adequate bone marrow function, a sufficient interval between their last dose of anti-cancer therapy and enrollment in the study for recovery purposes, as well as relapsed or refractory neuroblastoma; please contact individual sites for detailed criteria."

Answered by AI

Are Lab services hazard-free for individuals?

"Due to a limited amount of data regarding both efficacy and safety, the evaluation team at Power assigned Labs a score of 1 on their scale from 1-3."

Answered by AI

Could you provide details on past experiments related to Labs?

"First studied in 2012 at Azienda Ospedaliera Universitaria Federico II, 141 studies have been completed regarding Labs. Currently, 58 clinical trials are ongoing and many of these investigations are located in Philadelphia, Pennsylvania."

Answered by AI
Recent research and studies
~8 spots leftby Mar 2025