This clinical study is designed to provide continued access to patients who have previously participated in a dabrafenib and/or trametinib study and who in the opinion of the Investigator, would benefit from continued treatment

• Register: EUCTR
• Last refreshed on: 22 January 2018
• Main ID: EUCTR2017-001987-39-FR
• Date of registration: 15/01/2018
• Prospective Registration: No
• Primary sponsor: Novartis Pharma AG
• Public title: This clinical study is designed to provide continued access to patients who have previously participated in a dabrafenib and/or trametinib study and who in the opinion of the Investigator, would benefit from continued treatment
• Scientific title: 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
• Date of first enrolment: 19/12/2017
• Target sample size: 100
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001987-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Roll-over study; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Netherlands, Norway, Poland, Russian Federation, Slovakia, Spain, Sweden, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Information&Communication Médicale
• Affiliation: Novartis Pharma S.A.S.

• Name: Information&Communication Médicale
• Affiliation: Novartis Pharma S.A.S.

Key inclusion & exclusion criteria

Inclusion criteria:
Patients eligible for inclusion in this study have to meet all of the following criteria:
1. Patient is currently receiving treatment with dabrafenib/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. If the patient is a minor, the parent who signs the consent for the minor must be a legally recognized parent or guardian. Where deemed appropriate by the Investigator, and the child’s parent or guardian, the child will also be included in the all discussions about the trials and the minor’s assent if 7 years or older will be obtained.
7. Does not require treatment with prohibited concomitant medications
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Patients eligible for this study must not meet any of the following criteria:
1. Patient has been previously permanently discontinued from study treatment in the parent protocol due to any reason.
2. Patient’s indication is commercially available and reimbursed in the local country.
3. Patient has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication.
4. Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
5. Pregnant or nursing (lactating) women Female patients 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.
6. Concurrent treatment with other systemic anti-cancer therapies is not allowed (e.g., chemotherapy, immune, biologic, or targeted therapy), with the exception of radiotherapy.
7. Female patient is of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 150-days after stopping treatment. Highly effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
• Placement of a non-hormonal intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year.
• Double-barrier contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/cream/suppository).
Note: Hormonal-based methods (e.g., oral contraceptives) are not considered as highly effective methods of contraception due to potential drug-drug interactions with dabrafenib.
8. Sexually active males unless they use a condom during intercourse while on treatment and for 150 days after stopping treatment should not father a child in this period. A condom is required to be used by vasectomized men as well during intercourse in order to prevent delivery of the drug via semen.
9. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with BRAF V600 mutation positive
MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Tafinlar
Product Name: Tafinlar
Product Code: DRB436
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dabrafenib
Current Sponsor code: DRB436
Other descriptive name: DABRAFENIB MESYLATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Mekinist
Product Name: Mekinist
Product Code: TMT212
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TRAMETINIB
Current Sponsor code: TMT212
Other descriptive name: TRAMETINIB DIMETHYL SULFOXIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Mekinist
Product Name: Mekinist
Product Code: TMT212
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TRAMETINIB
Current Sponsor code: TMT212
Other descriptive name: TRAMETINIB DIMETHYL SULFOXIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: Tafinlar
Product Name: Tafinlar
Product Code: DRB436
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: dabrafenib
Current Sponsor code: DRB436
Other descriptive name: DABRAFENIB MESYLATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Primary endpoints will be evaluated throughout the study.

Secondary Objective: The secondary objective of the study is to evaluate clinical benefit as assessed by the Investigator. Proportion of patients with clinical benefit as assessed by the Investigator will be summarized at scheduled visits using FAS.

Main Objective: The primary objective is to evaluate long term safety as assessed by the occurrence of AEs/SAEs.

Primary end point(s): Frequency and severity of AEs/SAEs

Secondary Outcome(s)

Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator.

Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated during scheduled visits.

Secondary ID(s)

CDRB436X2X02B

Source(s) of Monetary Support

Novartis Pharma AG