Provide Continued Treatment with GSK1120212 to Subjects with Solid Tumors or Leukemia

Conditions: Cancer (solid tumors or leukemia)
MedDRA version: 14.1Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-023015-33-IT

Lead Sponsor: GlaxoSmithKline Research and Development LtdŒÚ°

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Has provided signed informed consent for this study.
2. Has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form.
3. Is currently participating in GSK1120212 study and is receiving treatment with GSK1120212.
4. Is currently receiving clinical benefit as determined by the investigator from previous treatment with GSK1120212 either as monotherapy or as part of a combination treatment regimen.
5. Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
6. Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 16 weeks after the last dose of GSK1120212.
7. Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 months after the last dose of GSK1120212.
8. Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
9. Subjects enrolled in France: 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in this study:
1. Permanent discontinuation of GSK1120212 in the parent study due to toxicity or disease progression.
2. Local access to commercially available GSK1120212.
3. Current use of a prohibitive medication(s) as listed in Section 6.2.
NOTE: Use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (INR) must be monitored in accordance with local institutional practice.
4. Any unresolved toxicity that meets the study treatment discontinuation or study withdrawal criteria from the parent study at the time of transition to this study.
5. Bazett-corrected QT (QTcB) interval =501 msec at the time of transition to this study
7. Left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN) by ECHO (preferred) or MUGA scan at the time of transition to this study.
9. Nursing female.
10. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to provide continued treatment with GSK1120212 for subjects who have previously participated in a GSK1120212 study and who continue to receive clinical benefit as well as have an acceptable safety profile with GSK1120212.;Secondary Objective: N/A;Primary end point(s): The primary objective of the study is to provide continued treatment with GSK1120212 for subjects who have previously participated in a GSK1120212 study and who continue to receive clinical benefit as well as have an acceptable safety profile with GSK1120212. No statistical hypotheses are being tested. Only descriptive methods will be used in<br>analysis of the data obtained from this study.<br>;Timepoint(s) of evaluation of this end point: The final analysis will take place after the last subject last visit has occurred.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A