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An Open-label, Multicenter, Single-arm, Phase I Dose-escalation With Efficacy Tail Extension Study of RO5185426 in Pediatric Patients With Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations Mutations


Phase 1
12 Years
17 Years
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

An Open-label, Multicenter, Single-arm, Phase I Dose-escalation With Efficacy Tail Extension Study of RO5185426 in Pediatric Patients With Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations Mutations


Inclusion Criteria:



- Pediatric patients, 12 to 17 years of age inclusive

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

- Positive BRAF mutation result (Cobas 4800 BRAF V600 Mutation Test)

- Measurable disease according to RECIST criteria

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

- Adequate bone marrow, liver and renal function

- Patients 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 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 HIV positivity or AIDS-related illness, active hepatitis B virus, or active
hepatitis C virus

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)/recommended dose

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO25390

NCT ID:

NCT01519323

Start Date:

January 2013

Completion Date:

September 2016

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts