An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)
- Conditions
- 10027655brain tumorsgliomas
- Registration Number
- NL-OMON51275
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 3
Subjects eligible for inclusion in this study must meet all of the following
criteria:
All subjects
1. Written informed consent, according to local guidelines, signed by the
patients and / or by the parents or legal guardian prior to any study related
screening procedures are performed.
2. Participation in a Novartis sponsored study such as TMT212X2101,
DRB436G2201, DRB436A2102, regardless of current age
3. Parent study (or cohort of parent study) is planned to be closed
4. Patient has demonstrated treatment compliance, as assessed by the
Investigator, within the parent study protocol requirement(s).
5. Willingness and ability to comply with scheduled visits, treatment plans and
any other study procedures.
For Subjects Entering the Treatment Period
6. Patient is currently receiving treatment with dabrafenib/trametinib
monotherapy or combination within a Novartis Sponsored Drug Development study.
7. In the opinion of the Investigator, the subject is likely to benefit from
continued treatment.
8. Does not require treatment with prohibited concomitant medications.
1. Patient has participated in a combination trial where dabrafenib and/or
trametinib was dispensed in combination with another study medication.
(Exception: Patients who were on the chemotherapy arm of the CDRB436G2201 study
are eligible for this study after crossing over into the experimental treatment
arm of the CDRB436G2201 study or have discontinued the study treatment and are
now in follow-up)
2. Patient has permanently discontinued from study treatment in the parent
protocol due to any reason.
3. Treatment with dabrafenib and/or trametinib for the patient*s indication is
approved for marketing and the appropriate dosage form is commercially
available and reimbursed in the local country
4. Patient currently has unresolved drug related severe toxicities for which
dabrafenib and/or trametinib dosing has been interrupted in the parent study.
If the patient should meet criteria to resume treatment on the parent protocol
then they may be eligible for enrolment in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Frequency and severity of (serious) adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy parameters according to the local standards, at least every 6 months. </p><br>