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Contact Information:

Study Location:

Sutton
SM2 5PT


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BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

Stopped

Open to: All Genders

Age: 12 Years - 17 Years

Medical Conditions

Malignant Melanoma


Study summary

This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.


Key dates

The recruitment start and end dates are as follows:

Jan 2013

Dec 2015

Study type

Interventional

Intervention Type : Drug
Intervention Name : vemurafenib
Intervention Description : Cohort 1 (participants >=45 kg): starting dose level 720mg; next dose level 960 mg Cohort 2 (participants <45 kg): starting dose 480 mg

Intervention Arm Group : Vemurafenib

Who can take part?

You can take part if:


Inclusion Criteria:

- Pediatric participants, 12 to 17 years of age inclusive

- Histologically confirmed surgically incurable and unresectable Stage IIIC or Stage IV (AJCC) melanoma

- Positive proto-oncogene B-Raf (BRAF) mutation result (Cobas 4800 BRAF V600 Mutation Test)

- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria

- Performance status: Karnofsky (for participants >/= 16 years of age) or Lansky (for participants < 16 years of age) score of >/= 60

- Adequate bone marrow, liver and renal function

- Participants must have fully recovered from the acute toxic effects of all prior therapy prior to first administration of study drug

Exclusion Criteria:

- Active or untreated central nervous system (CNS) lesions

- History of or known spinal cord compression or carcinomatous meningitis

- Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study

- Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ, and carcinoma in-situ of the cervix

- Previous treatment with selective/specific BRAF or Methyl Ethyl Ketone (MEK) inhibitor (previous treatment with sorafenib is allowed)

- Any previous treatment with study drug (RO5185426) or participation in a clinical trial that includes RO5185426

- Pregnant or lactating females

- Known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS)-related illness, active hepatitis B virus, or active hepatitis C virus




You may not be able to take part if:

This is in the inclusion criteria above


Where can I take part?

Below are the locations for where you can take part in the trial.

  • Sutton
    SM2 5PT
  • Newcastle Upon Tyne
    NE1 4LP

Funders/Sponsors


The study is sponsored by Hoffmann-La Roche .



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for Trial ID: NCT01519323

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