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Pediatric Long-Term Follow-up and Rollover Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03975829
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE November 4, 2019
Estimated Primary Completion Date December 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Number of participants with Adverse Events and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 7 years ]
To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Percentage of participants with height (measured by cm or in) changes over time [ Time Frame: Baseline up to approximately 7 years ]
    Developmental monitoring: Serial measurements of height will be collected throughout the study
  • Percentage of participants with weight (measured by kg or lb) changes over time [ Time Frame: Baseline up to approximately 7 years ]
    Developmental monitoring: Serial measurements of weight will be collected throughout the study
  • Percentage of participants with skeletal maturation (measured by bone age on x-ray or MRI) changes over time [ Time Frame: Baseline up to approximately 7 years ]
    Developmental monitoring: Serial measurements of skeletal maturation will be collected throughout the study
  • Percentage of participants with sexual maturation (measured by tanner staging criteria) changes over time [ Time Frame: Baseline up to approximately 7 years ]
    Developmental monitoring: Serial measurements of sexual maturation will be collected throughout the study
  • Percentage of participants with cardiac function (measured by ECG) changes over time [ Time Frame: Baseline up to approximately 7 years ]
    Developmental monitoring: Serial measurements of cardiac function will be collected throughout the study
  • Clinical Benefit (measured by CT/MRI) [ Time Frame: Baseline up to approximately 7 years ]
    Disease specific clinical benefit, as determined by investigator using institutional standard of care. Investigator will measure tumor response based on the Response Assessment used for the subject in the parent protocol (Response Assessment in Neuro-Oncology (RANO) criteria for solid tumors, RECIST, NF1 Volumetric, Neuroblastoma, or LCH criteria).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Long-Term Follow-up and Rollover Study
Official Title  ICMJE An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
Brief Summary A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diffuse Astrocytoma
  • Anaplastic Astrocytoma
  • Astrocytoma
  • Oligodendroglioma, Childhood
  • Anaplastic Oligodendroglioma
  • Glioblastoma
  • Pilocytic Astrocytoma
  • Giant Cell Astrocytoma
  • Pleomorphic Xanthoastrocytoma
  • Anaplastic Pleomorphic Xanthoastrocytoma
  • Angiocentric Glioma
  • Chordoid Glioma of Third Ventricle
  • Gangliocytoma
  • Ganglioglioma
  • Anaplastic Ganglioglioma
  • Dysplastic Gangliocytoma of Cerebrellum
  • Desmoplastic Infantile Astrocytoma and Ganglioglioma
  • Papillary Glioneuronal Tumor
  • Rosette-forming Glioneurona Tumor
  • Central Neurocytoma
  • Extraventricular Neurocytoma
  • Cerebellar Liponeurocytoma
  • Neurofibromatosis Type 1
Intervention  ICMJE
  • Drug: dabrafenib
    dabrafenib oral, twice daily
    Other Name: DRB436
  • Drug: trametinib
    trametinib oral, once daily
    Other Name: TMT212
Study Arms  ICMJE Experimental: Dabrafenib and/or trametinib

Patients in this study may receive one of the following treatments received in the parent study which are:

  • Patients who received monotherapy of either of dabrafenib or trametinib
  • Patients who received combination of dabrafenib and trametinib

    • Patients who discontinued treatment on parent study are still offered to participate in long-term follow-up
Interventions:
  • Drug: dabrafenib
  • Drug: trametinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

All Subjects:

  • Written informed consent, according to local guidelines, signed by the subjects and/or by the parents or legal guardian prior to any study related screening procedures are performed.
  • Participation in a Novartis sponsored study such as CTMT212X2101, CDRB436G2201, CDRB436A2102, regardless of current age.
  • Parent study (or cohort of parent study) is planned to be closed.
  • Subject has demonstrated compliance, as assessed by the investigator, within the parent study protocol requirement(s).
  • Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.

For Subjects Entering the Treatment Period:

  • Subject is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis Sponsored Drug Development study. Note that subjects who were on the chemotherapy arm of the CDRB436G2201 study are eligible for treatment period of this study only after crossing over into the experimental treatment arm of the CDRB436G2201 study
  • In the opinion of the investigator is likely to benefit from continued treatment.

Key Exclusion Criteria:

All Subjects:

- Subject has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication.

For Subjects Entering the Treatment Period:

  • Subject has permanently discontinued from study treatment in the parent protocol due to any reason.
  • Treatment with dabrafenib and/or trametinib for the subject's indication is approved for marketing and the appropriate dosage form is commercially available and reimbursed in the local country
  • Subject currently has unresolved drug related severe toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study. If the subject should meet criteria to resume treatment on the parent protocol then they may be eligible for treatment in this study.

Other protocol-defined inclusion/exclusion may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE France,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975829
Other Study ID Numbers  ICMJE CDRB436G2401
2018-004459-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

URL: https://www.clinicalstudydatarequest.com
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP