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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Adults who are or may become unable to consent;
Pregnant Women;


Hairy Cell Leukemia;
Anaplastic Thyroid Cancer;
Combination Therapy

Recruitment Keyword(s)



Hairy Cell Leukemia;
Anaplastic Thyroid Cancer

Investigational Drug(s)


Investigational Device(s)



Drug: dabrafenib
Drug: trametinib

Supporting Site

National Cancer Institute


Novartis sponsored a cancer study (#14C0131) that tested the use of the drugs dabrafenib and trametinib. Data from the study showed that approved doses of the drugs were safe when given together. Some study participants had good results from taking the drugs. Researchers want to learn more about the long-term effects of this cancer treatment.


To learn the long-term safety of dabrafenib and/or trametinib and to allow participants who benefited from the treatment on the Novartis study (#14C0131) to keep taking the drugs.


People who have taken part in Novartis parent study #14C0131 and have met the requirements for the primary objective of that study.


Participants will be screened with the tests they took in the parent study. They will give data about their health and medical history.

Participants will receive the study drug (or drugs) in the same way it was given on the parent study. The dose may be changed in this study, if needed. They will have a study visit at least once every 3 months. It will last 3 hours. At or between visits, they may have tests or imaging scans. They may take the drugs until they do not benefit from treatment or their cancer gets worse or comes back.

Participants will have a safety visit 30 days after they stop treatment. This visit may be done in person or by phone. They may be contacted for up to 6 months to give updates on their health.

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Subjects eligible for inclusion in this study have to meet all of the following criteria:

-Subject is currently receiving treatment with dabrafenib and/or trametinib 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.

-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.

-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.

-Does not require treatment with prohibited concomitant medications.


Subjects eligible for this study must not meet any of the following criteria:

-Subject has been previously permanently discontinued from study treatment in the parent protocol.

-Subject s indication is commercially available and reimbursed in the local country.

-Subject currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

-Female subjects who are lactating, unless they are willing discontinue nursing prior to first dose of study treatment, and willing to refrain from nursing throughout the treatment period and for 4 months following the last dose of study treatment.

-Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception whilst taking study treatment 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).

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.

--Bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy, total hysterectomy, or bilateral salpingectomy 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 is she considered to be not of child-bearing potential.

--Male sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to taking study drug.

--Dabrafenib monotherapy or in combination with trametinib: Placement of a intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year.

--Trametinib monotherapy only: Use of oral (estrogen and progesterone), injected or implanted combined hormonal methods of contraception or placement of an IUD or IUS, or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.

If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF.

Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g.,. age appropriate history of vasomotor symptoms). Women participants are considered not of child-bearing potential if they are post- menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral salpingectomy at least six weeks prior to enrollment in the study. In the case of oo horectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she not considered to be of childbearing potential.


-Double-barrier contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/cream/suppository) are not considered highly effective methods of contraception.

-Hormonal-based methods (e.g., oral contraceptives) are not considered as highly effective methods of contraception for subjects taking dabrafenib due to potential drug-drug interactions with dabrafenib.

-Sexually active males unwilling to use a condom during intercourse whilst taking study treatment and for:

--16 weeks after stopping study treatment with dabrafenib in combination with trametinib

--2 weeks after stopping study treatment with dabrafenib monotherapy

--16 weeks after stopping study treatment with trametinib monotherapy

A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner.

In addition, male participants must not donate sperm for the time period specified above.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Robert J. Kreitman, M.D.
National Cancer Institute (NCI)
(301) 648-7375

Olena Sierra Ortiz
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N254
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3185

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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