An Open Protocol for the Compassionate Use of Trametinib

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT02357446
• Date of registration: 03/02/2015
• Prospective Registration: No
• Primary sponsor: Cancer Centre of Monoclonal Therapy, LLC
• Public title: An Open Protocol for the Compassionate Use of Trametinib
• Scientific title: An Open Protocol for the Compassionate Use of Trametinib
• Date of first enrolment: January 2015
• Recruitment status: Temporarily not available
• URL: http://clinicaltrials.gov/show/NCT02357446
• Study type: Expanded Access
• Study design: N/A
• Phase: N/A

Countries of recruitment

Belarus, Czech Republic, Poland, Romania, Russian Federation, Ukraine

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients must have a confirmed malignancy which can be classified as locally
advanced or distant metastatic disease and must have either 1) failed on standard
therapy or 2) have disease for which in the opinion of the investigator, no adequate
standard +therapy exists when the development of tumors is associated with
pathological skin disease mutation V600E or V600K.

- Patients must be 18 years of age or older. Women of childbearing potential must have
a negative pregnancy test and fertile women and men must use a medically acceptable
means of birth control while on study and for 6 months thereafter.

- Histological verification of the mutation BRAF 600 E/K.

- SWOG Performance status 0-3, unless related to cancer pain.

- Before starting treatment, women of childbearing potential should have a negative
pregnancy test performed within 24 hours prior to beginning therapy.

- Pregnancy testing is not required for 1) women who have been post-menopausal for at
least 2 years with no menses, 2) women who have had a hysterectomy.

- Patients must have adequate hematologic function as demonstrated by total white blood
count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine <
or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or =1.5
mg/dl and transaminases < or =4 x ULN.

Exclusion Criteria:

- Patients with known untreated hepatitis C

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible; appropriate studies will be undertaken in patients receiving
combination antiretroviral therapy when indicated

- Patients with a known hypersensitivity to trametinib or other ingredients



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

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Drug: Trametinib

Secondary ID(s)

XTNWW-293-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Melanoma Research Foundation

World Cancer Research Fund International

Worldwide Cancer Research