A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.

JRCT ID: jRCT2031220699

Registered date:14/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma
• Date of first enrollment: 06/01/2023
• Target sample size: 2
• Countries of recruitment: United States,Japan,Belgium,Japan,Canada,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Netherlands,Japan,Russian Federation,Japan,Spain,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Dabrafenib (DRB436) :oral, twice daily
Trametinib (TMT212) : oral, once daily

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT03975829