A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma.
- Conditions
- BRAF mutation positive metastatic melanomaMedDRA version: 12.1Level: LLTClassification code 10025670Term: Malignant melanoma stage IIIMedDRA version: 12.1Level: LLTClassification code 10025671Term: Malignant melanoma stage IV
- Registration Number
- EUCTR2009-015298-11-NL
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Subjects eligible for enrolment in the study must meet all of the following criteria:
1.Has provided signed informed consent.
2.Histologically confirmed advanced (unresectable Stage III) or metastatic melanoma (Stage IV) and BRAF mutation-positive (V600 E) melanoma as determined via central testing with a BRAF mutation assay.
3.Are treatment naïve for advanced (unresectable) or metastatic melanoma, with the exception of IL-2 which is allowed.
4.Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
5.Age =18 years of age
6.Able to swallow and retain oral medication.
7.Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study. Additionally, women of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study treatment.
8.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
9.Must have adequate organ function as defined in the protocol (Retesting of borderline screening organ function will be allowed. Treatment with transfusion, growth factors to meet eligibility criteria will not be allowed):
10.French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
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
Subjects meeting any of the following criteria must not be enrolled in the study:
1.Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
2.Known ocular or primary mucosal melanoma.
3.Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, or surgery).
4.Use of any investigational anti-cancer or other drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of GSK2118436.
5.Current use of a prohibited medication or is expected to require any of these medications during treatment with GSK2118436.
6.Any major surgery, radiotherapy, or immunotherapy within the last 4 weeks.
7.Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GSK medical monitor for permission to enroll the subject.
8.A history of Human Immunodeficiency Virus (HIV) infection
9.A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
10.A history of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
11.Evidence of active CNS disease (radiographically unstable, symptomatic lesions). However prior treatment with stereotactic radiosurgery (SRS) or surgical resection is allowed if the subject remains without evidence of disease progression in the brain = 3 months, and has been off corticosteroids = 3 weeks. Whole brain radiotherapy is not allowed except in those subjects who have had definitive resection or SRS of all radiographically detectable parenchymal lesions.
12.History of alcohol or drug abuse within 6 months prior to Screening.
13.Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, or unwillingness or inability to follow the procedures required in the protocol.
14.The following cardiac abnormalities:
•Corrected QT (QTc) interval = 480 msecs
•History of acute coronary syndromes (including unstable angina) within the past 24 weeks.
•Coronary angioplasty, or stenting within the past 24 weeks.
•Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
•Abnormal cardiac valve morphology (= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [ie, mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
•History of known cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks.
•Known cardiac metastases.
15.Pregnant or lactating female.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method