Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

Study Identifier:
CDRB436X2X02B
CT.gov Identifier:
NCT03340506
EudraCT Identifier:
2017-001987-39
EU Trial (CTIS) Number:
2023-509318-13-00
Study Contact Information:
N/A
Recruiting

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Study Summary

To provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment n the parent study as judged by the Investigator at the completion of the parent study.

The purpose of this trial was to achieve the objectives set in the trial conducted by Novartis or former developer GSK as a sponsor and to provide treatment opportunities for subjects currently receiving dabrafenib, trametinib, or both. It is to be.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Solid Tumor
  • Unspecified Cancer
  • High Grade Glioma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    IV
    Sex
    Female & Male
    Age
    18 - 100 Years
    Study Drug
  • Drug: Arms: Experimental: dabrafenib monotherapy Patients in this study may receive: - monotherapy of dabrafenib Intervention/treatment: Drug: dabrafenib dabrafenib is available in capsules (50mg and 75mg) taken twice a day Experimental: trametinib monotherapy Patients in this study may receive: - monotherapy of trametinib Intervention/treatment
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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.
    • In the opinion of the Investigator would benefit from continued treatment.
    • Patient 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.
    • 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.
    • 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.
    • Does not require treatment with prohibited concomitant medications
    Exclusion criteria
    • Patient has been previously permanently discontinued from study treatment in the parent protocol.
    • Patient's indication is commercially available and reimbursed in the local country.
    • Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
    • 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.
    • Concurrent treatment with other systemic anti-cancer therapies is not allowed (e.g., chemotherapy, immune, biologic, or targeted therapy), with the exception of radiotherapy.
    • 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.
    • 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.
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Melanoma
    Non-Small Cell Lung Cancer
    Solid Tumor
    Unspecified Cancer
    High Grade Glioma
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Juan José Soto
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Melanoma
    Non-Small Cell Lung Cancer
    Solid Tumor
    Unspecified Cancer
    High Grade Glioma