Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

August 9, 2017 updated by: GlaxoSmithKline

An Open Label Non Randomized Access Study of Trametinib for Patients With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV). Trametinib may be given as monotherapy or in combination since first line metastatic melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they have not progressed under such treatment or if they have presented limited progression as per eligibility criteria. It is estimated that between 250 and 400 subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens Cedex, France, 80054
        • GSK Investigational Site
      • Angers, France, 49100
        • GSK Investigational Site
      • Bayonne cedex, France, 64109
        • GSK Investigational Site
      • Besancon cedex, France, 25030
        • GSK Investigational Site
      • Bobigny, France, 93000
        • GSK Investigational Site
      • Bordeaux, France, 33075
        • GSK Investigational Site
      • Boulogne-Billancourt, France, 92100
        • GSK Investigational Site
      • Brest cedex, France, 29609
        • GSK Investigational Site
      • Caen Cedex 9, France, 14033
        • GSK Investigational Site
      • Chambray-Les-Tours, France, 37170
        • GSK Investigational Site
      • Clermont-Ferrand cedex 1, France, 63003
        • GSK Investigational Site
      • Creteil, France, 94010
        • GSK Investigational Site
      • Dijon Cedex, France, 21079
        • GSK Investigational Site
      • Grenoble cedex 9, France, 38043
        • GSK Investigational Site
      • La Rochelle cedex 1, France, 17019
        • GSK Investigational Site
      • Le Havre, France, 76083
        • GSK Investigational Site
      • Le Mans, France, 72000
        • GSK Investigational Site
      • Lille, France, 59037
        • GSK Investigational Site
      • Limoges cedex, France, 87042
        • GSK Investigational Site
      • Lorient, France, 56322
        • GSK Investigational Site
      • Lyon Cedex 08, France, 69373
        • GSK Investigational Site
      • Marseille Cedex 5, France, 13385
        • GSK Investigational Site
      • Montpellier Cedex 5, France, 34298
        • GSK Investigational Site
      • Montpellier cedex 5, France, 34295
        • GSK Investigational Site
      • Mulhouse, France, 68100
        • GSK Investigational Site
      • Nantes Cedex 1, France, 44093
        • GSK Investigational Site
      • Nice, France, 06202
        • GSK Investigational Site
      • Nimes, France, 30029 cedex 9
        • GSK Investigational Site
      • Orleans Cedex 2, France, 45067
        • GSK Investigational Site
      • Paris, France, 75006
        • GSK Investigational Site
      • Paris Cedex 10, France, 75475
        • GSK Investigational Site
      • Pau, France, 64000
        • GSK Investigational Site
      • Pierre-Benite cedex, France, 69495
        • GSK Investigational Site
      • Poitiers, France, 86021
        • GSK Investigational Site
      • Pringy Cedex, France, 74374
        • GSK Investigational Site
      • Reims Cedex, France, 51092
        • GSK Investigational Site
      • Rennes Cedex, France, 35042
        • GSK Investigational Site
      • Rouen, France, 76031
        • GSK Investigational Site
      • Saint-Pierre, France, 97448
        • GSK Investigational Site
      • Saint-Priest en Jarez, France, 42270
        • GSK Investigational Site
      • Strasbourg Cedex, France, 67091
        • GSK Investigational Site
      • Thionville, France, 57126 Cedex 1
        • GSK Investigational Site
      • Toulouse Cedex 9, France, 31059
        • GSK Investigational Site
      • Valence Cedex 9, France, 26953
        • GSK Investigational Site
      • Vandoeuvre-Les-Nancy, France, 54511
        • GSK Investigational Site
      • Villejuif cedex, France, 94805
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provides signed and dated informed consent, with age at the time of consent >=18 years.
  • Has histologically confirmed cutaneous melanoma BRAF V600E/K positive mutation either unresectable (stage IIIc) or distant metastatic (stage IV).
  • Is not eligible for enrolment in any other ongoing relevant hypothesis testing clinical study for metastatic melanoma or, if eligible, is so geographically distant from a participating site that attending frequent clinic visits is not feasible.
  • Has not participated in the following GSK sponsored clinical studies (COMBI-v: MEK116513, COMBI-d: MEK115306, COMBI-AD: BRF115532) for melanoma indication prior to participating in this open label access study.
  • Is able to swallow and retain oral medication.
  • For subjects with active brain metastases: the subject does not require or is ineligible for immediate local treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 and in stable clinical condition. NOTE: subject in rapidly deteriorating clinical condition prior to start of therapy should not be considered for this open label access study. ECOG 3 subjects may be included provided the subject is clinically stable on the investigator's judgement.
  • Does not require treatment with another anti-cancer therapy while on this open label access study (except dabrafenib if in combination with trametinib).
  • Does not require treatment with prohibited concomitant medications.
  • Does not have any medical conditions or physical examination or clinical laboratory findings which, in the opinion of the investigator and/or GSK Medical Monitor, would put the subject at high risk for an adverse outcome.
  • Where applicable, female subjects of childbearing potential must agree to use one of the contraceptive methods listed in the study protocol. These subjects must have a negative serum pregnancy test within 7 days prior to the first dose of trametinib, preferably as close to the first dose as possible, agree to use adequate contraception from the time of the pregnancy test, throughout the treatment period and for a total of 4 months following the last dose of treatment.
  • For subjects enrolled in France: a subject will be eligible for inclusion in this study only if he is, either affiliated to or beneficiary of a social security category.

Exclusion Criteria:

  • Subjects who have received prior therapy with a MEK or BRAF inhibitor. NOTE: However subjects may be eligible in the following cases: Subjects whose tumor has not progressed based on radiographic and clinical assessments. Such subjects may receive therapy with: trametinib in combination with dabrafenib (in case of an adverse event related to a previous BRAF or MEK inhibitor other than trametinib or dabrafenib and without cross-reaction anticipated, or if clinically indicated according to investigator judgement). Prior treatment (except trametinib and dabrafenib) should have been stopped for a period of 5 half lives or 28 days (whichever is shorter) before starting treatment of this study; trametinib monotherapy if the subject has benefited from a treatment with a BRAF-inhibitor without progression but cannot receive it anymore due to tolerability reason. Subjects who have met the criteria for disease progression may receive trametinib in combination with dabrafenib if: the disease progression was confirmed after a period of at least 6 months of clinical benefit (Response or Stable Disease) on monotherapy and if the progression was characterized by a limited radiographic progression in the absence of clinical signs and symptoms of progression. no treatment-related grade 4 AEs or any SAEs occurred during the last 4 weeks of treatment.
  • Concurrent treatment with other systemic anti-cancer therapies is not allowed (except dabrafenib in combination with trametinib). Subjects who are currently being treated with another systemic anti-cancer therapy (e.g. chemo, immune, biologic, or targeted therapy) must discontinue use prior to initiation of treatment in this open label access study for a period of 5 half lives or 28 days (whichever is shorter).
  • Presence of malignancy other than melanoma within 1 year of enrolment into this program or any malignancy with confirmed activating RAS mutation. Subject with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.
  • Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib or dabrafenib, or excipients or to dimethyl sulfoxide (DMSO).
  • Current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
  • Current evidence of cardiovascular risk including any of the following: Left Ventricular Ejection Fraction (LVEF) < lower limit of normal (LLN); A QT interval corrected for heart rate using the Bazett's formula >=480 millisecond (msec); Clinically significant uncontrolled arrhythmias; Acute coronary syndromes (including myocardial infarction and unstable angina); Congestive heart failure >=Class II as defined by New York Heart Association.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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