An open label, multi-center roll-over study to assess long-term safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment
- Conditions
- various rare malignant tumors10027655
- Registration Number
- NL-OMON51217
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
Patients eligible for inclusion in this study have to meet all of the following
criteria:
1. Patient is currently receiving treatment with dabrafenib and/or trametinib
monotherapy or combination within a Novartis or former GSK sponsored study
which has fulfilled the requirements for the primary objective.
2. In the opinion of the Investigator would benefit from continued treatment.
3. Patient has demonstrated compliance, as assessed by the Investigator, within
the parent study protocol requirement(s).
4. Willingness and ability to comply with scheduled visits, treatment plans and
any other study procedures.
5. Written informed consent obtained prior to enrolling in the roll-over study
and receiving study medication. If consent cannot be expressed in writing, it
must be formally documented and witnessed, ideally via an independent trusted
witness.
6. Does not require treatment with prohibited concomitant medications
Subjects eligible for this study must not meet any of the following criteria:
1. Subject has been previously permanently discontinued from study treatment in
the parent protocol due to any reason.
2. Subject*s indication is commercially available and reimbursed in the local
country.
3. Subject currently has unresolved toxicities for which dabrafenib and/or
trametinib dosing has been interrupted in the parent study.
4. Pregnant or nursing (lactating) women who are lactating must discontinue
nursing prior to the first dose of study treatment and must refrain from
nursing throughout the treatment period and for 4 months following the last
dose of study treatment.
5. Women of childbearing potential, defined as all women physiologically
capable of becoming pregnant, must use highly effective methods of
contraception during dosing and for 16 weeks after stopping treatment with
trametinib (for trametinib monotherapy trials); 2 weeks after stopping
treatment with dabrafenib (for dabrafenib monotherapy trials); 16 weeks after
stopping treatment with trametinib or 2 weeks after stopping treatment with
dabrafenib whichever is longer (for trials of dabrafenib in combination with
trametinib). For more information, please refer to the protocol.
6. Sexually active males (including those that have had a vasectomy) taking the
dabrafenib and/or trametinib therapy must use a condom during intercourse, and
should not father a child during this period. The minimum amount of time a
subject must use a condom after last treatment is as follows:
• 16 weeks post treatment discontinuation dabrafenib in combination with
trametinib
• 2 weeks after treatment with dabrafenib monotherapy
• 16 weeks after treatment with trametinib monotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to evaluate long term safety as assessed by occurrence<br /><br>of AEs/SAEs. Endpoint: Frequency and severity of AEs/SAEs</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate clinical benefit as assessed by the Investigator. Endpoint:<br /><br>Proportion of subjects with clinical benefit as assessed by the<br /><br>Investigator at scheduled visits.</p><br>