Clinical Study To Evaluate the Recommended Dose, Safety,Pharmacokinetics and Efficacy of RO5185426 in Paediatric Patients 12 to17 Years Old With BRAFV600 Mutation Positive

• Conditions: Metastatic Melanoma; MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000874-67-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients with histologically confirmed surgically incurable and
unresectable stage IIIC or stage IV (AJCC) melanoma. Unresectable
stage IIIC disease must have confirmation from a surgical oncologist.
2.Patients must have a positive BRAF mutation result determined by a Roche-designated central reference laboratory using the cobas 4800
BRAF V600 Mutation Test prior to administration of RO5185426.
3.Patients may have newly diagnosed melanoma or have completed and
failed prior standard of care regimen (e.g., DTIC, temozolomide, etc.).
4.Measurable disease according to RECIST criteria Version 1.1
5. Must have a head CT/MRI to evaluate for CNS metastasis within 28
days prior to treatment. Patients with radiographically stable,
asymptomatic previously treated lesions are eligible provided:
-Patient has received prior treatment [including radiation therapy
(whole brain radiotherapy is not allowed with the exception of patients
who have also had definitive resection or stereotactic therapy of all
radiologically detectable parenchymal lesions), stereotactic
radiosurgery, surgical resection] to the site(s) of CNS metastatic disease
= 3 months prior to starting study treatment
-Patient has no requirement for glucocorticoids, and discontinued = 21
days prior to starting study treatment
- Patient is not taking anticonvulsants (discontinued at least 3 weeks
prior to treatment)
6.Patients aged = 12 to = 17 years
7.Performance Status: Karnofsky (for patients =16 years of age) or
Lansky (for patients < 16 years of age) score = 60
8.Patients must have recovered from effects of any major surgery or
significant traumatic injury at least 14 days prior to administration of the
first dose of study treatment.
9.Life expectancy > 3 months.
10. Adequate hematologic, renal and liver function as defined by
laboratory values performed within 28 days prior to initiation of dosing.
11.Completed baseline skin exam by a dermatologist for cutaneous
squamous cell carcinoma. Exam must be negative or if, suspected
cutaneous SCC lesions are identified they must be excised, and there
must be adequate wound healing prior to study treatment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

2.History of or known spinal cord compression, or carcinomatous
meningitis.
3.Negative result for BRAF mutation as determined using the Roche
cobas 4800 BRAF V600 Mutation Test
4.Anticipated or ongoing administration of anti-cancer therapies other
than those administered in this study.
5.Patients with a previous malignancy within the past 5 years are
excluded except for patients with basal or squamous cell carcinoma
(SCC) of the skin, melanoma in-situ, and carcinoma in-situ of the cervix.
6.Patients who have been previously treated with a selective/specific
BRAF or MEK inhibitor (previous treatment with sorafenib is allowed).
7.Patients who have had any previous treatment with study drug
(RO5185426) or participated in a clinical trial that includes RO5185426.
8.QTc >450 msec on screening or baseline ECG or history of congential
long QT syndrome.
9.NCI-CTCAE Version 4.0 grade 3 hemorrhage within 4 weeks of starting
the study treatment.
10.Any of the following within the 6 months prior to study drug
administration: myocardial infarction, severe/unstable angina,
coronary/peripheral artery bypass graft, symptomatic congestive heart
failure, serious cardiac arrhythmia requiring medication, uncontrolled
hypertension, cerebrovascular accident or transient ischemic attack, or
symptomatic pulmonary embolism.
11.Known clinically significant active infection at the time of study
treatment start, at the time of screening or within 14 days of study drug start.
12.History of allogeneic bone marrow transplantation or organ
transplantation.
of the investigator would make the patient inappropriate for entry into
this study.
13.Known HIV positivity or AIDS-related illness, or active HBV, and
active HCV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified