A Comparative Study Efficacy of Trametinib (CT) in Comparison With Trametinib (MEKINIST)

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT02402790
• Date of registration: 22/03/2015
• Prospective Registration: No
• Primary sponsor: Cancer Centre of Monoclonal Therapy, LLC
• Public title: A Comparative Study Efficacy of Trametinib (CT) in Comparison With Trametinib (MEKINIST)
• Scientific title: A Comparative Study Efficacy of Trametinib (CT) in Comparison With Trametinib (MEKINIST) in Patients With BRAF V600E or V600K Mutation-positive Solid Tumors
• Date of first enrolment: February 2014
• Target sample size: 202
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT02402790
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belarus, Germany, Poland, Romania, Russian Federation, Ukraine

Contacts

• Name: Viktor Lanevskij, PhD
• Affiliation: Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed, written informed consent.

- Sex: male or female.

- Age: >=18 years of age at the time of providing informed consent.

- Eastern Cooperative Oncology Group (ECOG) performance status: 0, 1 or 2.

- BRAF V600E mutation-positive tumor: Local testing - Local BRAF mutation test results
obtained by a Clinical Laboratory Improvement Amendments (CLIA) approved local
laboratory may be used to permit enrollment of subjects with positive results. Local
BRAF mutation test results will be subject to central verification; Central testing -
Local BRAF mutation test results will be confirmed by central testing in a CLIA
approved, designated central reference laboratory by the THxID BRAF assay or an
alternate GSK designated assay. NOTE: For central testing, Formalin-fixed
paraffin-embedded (FFPE) core bone marrow (BM) biopsies are not acceptable from
subjects in the Multiple myeloma (MM) cohort.

- Able to swallow and retain orally administered medication. NOTE: Subject should not
have any clinically significant gastrointestinal (GI) abnormalities that may alter
absorption such as malabsorption syndrome or major resection of the stomach or
bowels. For example, subjects should have no more than 50% of the large intestine
removed and no sign of malabsorption (i.e., diarrhea).NOTE: If clarification is
needed as to whether a condition will significantly affect the absorption of study
treatments, contact the GSK Medical Monitor.

- Female Subjects of Childbearing Potential: Subjects must have a negative serum
pregnancy test within 7 days prior to the first dose of study treatment and agrees to
use effective contraception, throughout the treatment period and for 4 months after
the last dose of study treatment.

Exclusion Criteria:

- Prior treatment with any BRAF inhibitor or any mitogen-activated
protein/extracellular signal-regulated kinase inhibitor.

- Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without
delayed toxicity within treatment specific timeframe.

- Treatment with stereotactic radiosurgery or treatment with whole-brain radiation
within treatment specific timeframe.

- Any presence of leptomeningeal disease or any parenchymal brain metastasis

- History of another malignancy, some exceptions may apply.

- A history or evidence of cardiovascular risk- specific criteria have to be met

- A history or current evidence/risk of retinal vein occlusion or retinal pigment
epithelial detachment - specific criteria have to be met.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Drug: Trametinib

Primary Outcome(s)

the efficacy of Trametinib (CT) and Trametinib (Mekinist GSK) by comparing the best confirmed objective response rate (ORR) in treatment for patients with BRAF V600E or V600K mutation-positive solid tumors [Time Frame: up to 54 weeks]

Secondary Outcome(s)

Number of Participants With Progression Free Survival (PFS) [Time Frame: up to 54 weeks]

Secondary ID(s)

XTPTC-308-61

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The European Association for Cancer Research

Melanoma Research Foundation