E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cancer (solid tumors or leukemia) |
|
E.1.1.1 | Medical condition in easily understood language |
Cancer (solid tumors or leukemia) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027481 |
E.1.2 | Term | Metastatic melanoma |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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
6. 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.
7. Nursing female.
8. 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. |
|
E.5 End points |
E.5.1 | 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
analysis of the data obtained from this study.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The final analysis will take place after the last subject last visit has occurred. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
A Rollover Study to Provide Continued Treatment with GSK1120212 |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
A Rollover Study to Provide Continued Treatment with GSK1120212 |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Belgium |
France |
Germany |
Greece |
Italy |
Korea, Republic of |
New Zealand |
Poland |
Russian Federation |
Sweden |
Switzerland |
Taiwan |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |