A Phase III randomized, open-label study comparing GSK1120212 to chemotherapy in subjects with advanced or metastatic BRAF V600E/K mutation-positive melanoma - ND

Phase 1

• Conditions: advanced or metastatic BRAF V600E/K mutation-positive melanoma; MedDRA version: 9.1Level: LLTClassification code 10027481

• Registration Number: EUCTR2010-022838-85-IT
• Lead Sponsor: GlaxoSmithkline Research and Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-02
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 297

Inclusion Criteria

Signed written informed consent. =18 years of age.Histologically confirmed, Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory.Subjects may have received no prior treatment or up to one prior regimen of chemotherapy for advanced or metastatic melanoma. Prior treatment with immunotherapy (with the exception of prior ipilimumab, which is only allowed if given in the adjuvant setting), cytokine therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any prior use of: a. BRAF inhibitors or MEK inhibitors. b. Ipilimumab in the advanced or metastatic setting. Subjects who have received dacarbazine or paclitaxel prior to randomization will not be eligible to receive the same chemotherapy as study medication (i.e. a subject who received prior dacarbazine cannot receive dacarbazine on this trial and would thus receive paclitaxel if randomized to the control arm).Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy or immunotherapy within the last 21 days. Chemotherapy given daily or weekly without the potential for delayed toxicity within the last 14 days. Administration of an investigational drug within 28 days or 5 half-lives,(whichever is shorter), prior to randomization – at least 14 days must have passed between the last dose of the prior investigational anti-cancer drug and randomization.Current use of any prohibited medication (see Section 6). Use of anticoagulants such as warfarin is permitted, however INR must be monitored in accordance with local institutional practice.History of another malignancy. Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above.Any serious and/or unstable pre-existing medical (aside from malignancyexception above), psychiatric disorder, or other conditions that could interferewith subject’s safety, obtaining informed consent or compliance to the studyprocedures.Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed). Brain metastases with the following exceptions that are ALL confirmed by theGSK Medical Monitor: c. All known lesions must be previously treated with surgery or stereotactic radiosurgery, and d. Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for =90 days prior to randomization (must be documented with two consecutive MRI or CT scans using contrast), and c. Asymptomatic with no corticosteroids requirement for = 30 days prior to randomization, and e. No enzyme-inducing anticonvulsants for = 30 days prior to randomization. History or evidence of cardiovascular risk including any of the following: f. QTcB = 480 msec. g. History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible. h. History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization. i. History or evidence of current = Class II congestive heart failure as defined by New York Heart Association. History of interstitial lung disease or pneumonitis. History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR): • History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).

Study & Design

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