Melanoma Clinical Trial

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

Summary

This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

≥18 years of age
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
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, biological or vaccine regimen is permitted. Prior use of sorafenib is allowed
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Women of childbearing potential and men with reproductive potential must agree to use effective contraception during the study. Additionally women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Adequate screening organ function

Exclusion Criteria:

Any prior use of BRAF inhibitors or MEK inhibitors.
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)
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
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 the GSK Medical Monitor:

All known lesions must be previously treated with surgery or stereotactic radiosurgery, and 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 asymptomatic with no corticosteroids requirement for ≥ 30 days prior to randomization, and no enzyme-inducing anticonvulsants for ≥ 30 days prior to randomization

History or evidence of cardiovascular risk including any of the following:

QTcB ≥ 480 msec.
History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible
History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
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).
Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
Evidence of new optic disc cupping.
Intraocular pressure > 21 mm Hg as measured by tonography

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

322

Study ID:

NCT01245062

Recruitment Status:

Completed

Sponsor:

GlaxoSmithKline

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There are 111 Locations for this study

See Locations Near You

GSK Investigational Site
Tucson Arizona, 85724, United States
GSK Investigational Site
Fort Myers Florida, 33916, United States
GSK Investigational Site
Athens Georgia, 30607, United States
GSK Investigational Site
Marietta Georgia, 30060, United States
GSK Investigational Site
Iowa City Iowa, 52242, United States
GSK Investigational Site
Metairie Louisiana, 70006, United States
GSK Investigational Site
Boston Massachusetts, 02114, United States
GSK Investigational Site
Morristown New Jersey, 07962, United States
GSK Investigational Site
Columbus Ohio, 43210, United States
GSK Investigational Site
Columbia South Carolina, 29210, United States
GSK Investigational Site
Chattanooga Tennessee, 37404, United States
GSK Investigational Site
Memphis Tennessee, 38120, United States
GSK Investigational Site
Nashville Tennessee, 37203, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires , C1121, Argentina
GSK Investigational Site
Garran Australian Capital Territory, 2606, Australia
GSK Investigational Site
Port Macquarie New South Wales, 2444, Australia
GSK Investigational Site
Waratah New South Wales, 2300, Australia
GSK Investigational Site
South Brisbane Queensland, 4101, Australia
GSK Investigational Site
Townsville Queensland, 4810, Australia
GSK Investigational Site
Woolloongabba Queensland, 4102, Australia
GSK Investigational Site
Kurralta Park South Australia, 5037, Australia
GSK Investigational Site
Woodville South Australia, 5011, Australia
GSK Investigational Site
Heidelberg Victoria, 3084, Australia
GSK Investigational Site
Melbourne Victoria, 3004, Australia
GSK Investigational Site
Graz , 8036, Austria
GSK Investigational Site
Wien , 1090, Austria
GSK Investigational Site
Brussels , 1200, Belgium
GSK Investigational Site
Charleroi , 6000, Belgium
GSK Investigational Site
Gent , 9000, Belgium
GSK Investigational Site
Jette , 1090, Belgium
GSK Investigational Site
Kortrijk , 8500, Belgium
GSK Investigational Site
Leuven , 3000, Belgium
GSK Investigational Site
Wilrijk , 2610, Belgium
GSK Investigational Site
Yvoir , 5530, Belgium
GSK Investigational Site
Calgary Alberta, T2N 4, Canada
GSK Investigational Site
Vancouver British Columbia, V5Z 4, Canada
GSK Investigational Site
Halifax Nova Scotia, B3H 2, Canada
GSK Investigational Site
Hamilton Ontario, L8V 5, Canada
GSK Investigational Site
London Ontario, N6A 4, Canada
GSK Investigational Site
Oshawa Ontario, L1G 2, Canada
GSK Investigational Site
Ottawa Ontario, K1H 8, Canada
GSK Investigational Site
Toronto Ontario, M5G 2, Canada
GSK Investigational Site
Montreal Quebec, H2L 4, Canada
GSK Investigational Site
Montreal Quebec, H2W 1, Canada
GSK Investigational Site
Hradec Kralove , 500 0, Czechia
GSK Investigational Site
Ostrava , 708 5, Czechia
GSK Investigational Site
Praha 2 , 128 0, Czechia
GSK Investigational Site
Zlin , 76275, Czechia
GSK Investigational Site
Boulogne-Billancourt , 92100, France
GSK Investigational Site
Grenoble , 38043, France
GSK Investigational Site
Montpellier , 34295, France
GSK Investigational Site
Nantes , 44093, France
GSK Investigational Site
Paris Cedex 10 , 75475, France
GSK Investigational Site
Pierre-Benite cedex , 69495, France
GSK Investigational Site
Rennes , 35042, France
GSK Investigational Site
Tours , 37044, France
GSK Investigational Site
Villejuif , 94805, France
GSK Investigational Site
Heidelberg Baden-Wuerttemberg, 69120, Germany
GSK Investigational Site
Mannheim Baden-Wuerttemberg, 68167, Germany
GSK Investigational Site
Tuebingen Baden-Wuerttemberg, 72076, Germany
GSK Investigational Site
Muenchen Bayern, 80804, Germany
GSK Investigational Site
Wuerzburg Bayern, 97080, Germany
GSK Investigational Site
Buxtehude Niedersachsen, 21614, Germany
GSK Investigational Site
Essen Nordrhein-Westfalen, 45122, Germany
GSK Investigational Site
Dresden Sachsen, 01307, Germany
GSK Investigational Site
Luebeck Schleswig-Holstein, 23538, Germany
GSK Investigational Site
Berlin , 10117, Germany
GSK Investigational Site
Athens , 11527, Greece
GSK Investigational Site
Athens , 185 4, Greece
GSK Investigational Site
Thessaloniki , 564 2, Greece
GSK Investigational Site
Milano Lombardia, 20132, Italy
GSK Investigational Site
Milano Lombardia, 20133, Italy
GSK Investigational Site
Milano Lombardia, 20141, Italy
GSK Investigational Site
Pisa Toscana, 56126, Italy
GSK Investigational Site
Christchurch , 8011, New Zealand
GSK Investigational Site
Dunedin , 9016, New Zealand
GSK Investigational Site
Newtown, Wellington , 6002, New Zealand
GSK Investigational Site
Oslo , 0310, Norway
GSK Investigational Site
Poznan , 61-86, Poland
GSK Investigational Site
Warszawa , 02-78, Poland
GSK Investigational Site
Warszawa , 04-12, Poland
GSK Investigational Site
Chelyabinsk , 45408, Russian Federation
GSK Investigational Site
Magnitogorsk , 45500, Russian Federation
GSK Investigational Site
Moscow , 11547, Russian Federation
GSK Investigational Site
St. Petersburg , 19775, Russian Federation
GSK Investigational Site
Goteborg , SE-41, Sweden
GSK Investigational Site
Linkoping , SE-58, Sweden
GSK Investigational Site
Lund , SE-22, Sweden
GSK Investigational Site
Stockholm , SE-17, Sweden
GSK Investigational Site
Uppsala , SE-75, Sweden
GSK Investigational Site
Zurich , 8091, Switzerland
GSK Investigational Site
Dnepropetrovsk , 49102, Ukraine
GSK Investigational Site
Kharkiv , 61070, Ukraine
GSK Investigational Site
Kyiv , 03022, Ukraine
GSK Investigational Site
Kyiv , 03115, Ukraine
GSK Investigational Site
Lviv , 79031, Ukraine
GSK Investigational Site
Sumy , 40005, Ukraine
GSK Investigational Site
Sympheropol , 95023, Ukraine
GSK Investigational Site
Ternopil , 46023, Ukraine
GSK Investigational Site
Uzhgorod , 88017, Ukraine
GSK Investigational Site
Cambridge Cambridgeshire, CB2 2, United Kingdom
GSK Investigational Site
Northwood Middlesex, HA6 2, United Kingdom
GSK Investigational Site
Sutton Surrey, SM2 5, United Kingdom
GSK Investigational Site
Aberdeen , AB25 , United Kingdom
GSK Investigational Site
Birmingham , B15 2, United Kingdom
GSK Investigational Site
Chelmsford , CM1 7, United Kingdom
GSK Investigational Site
Leeds , LS9 7, United Kingdom
GSK Investigational Site
London , SW3 6, United Kingdom
GSK Investigational Site
London , W1G 6, United Kingdom
GSK Investigational Site
Manchester , M20 4, United Kingdom
GSK Investigational Site
Oxford , OX3 7, United Kingdom
GSK Investigational Site
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

322

Study ID:

NCT01245062

Recruitment Status:

Completed

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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