Last updated: 11/03/2018 16:34:51
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
MEK114375: A Rollover Study to Provide Continued Treatment with GSK1120212 to Subjects with Solid Tumors and Leukemia
GSK study ID
114375
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: MEK114375: A Rollover Study to Provide Continued Treatment with GSK1120212 to Subjects with Solid Tumors and Leukemia
Trial description: This is an open-label study which will permit subjects with solid tumors or leukemia, who are currently clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with adverse events
Timeframe: From date of transition into this Rollover study until 28 days following the last dose. Subjects may continue to receive study medication until disease progression, death, or unacceptable adverse event: there is no time limit for this outcome measure.
Secondary outcomes:
Not applicable
Interventions:
Drug: Everolimus + GSK1120212
Drug: Gemcitabine + GSK1120212
Drug: Carboplatin + GSK1120212
Drug: Docetaxel + GSK1120212
Drug: Nab-paclitaxel + GSK1120212
Drug: Erlotinib + GSK1120212
Drug: Pemetrexed + GSK1120212
Drug: GSK1120212
Enrollment:
250
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
trametinib
Collaborators
Not applicable
Study date(s)
March 2011 to June 2018
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 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.
- 1. Permanent discontinuation of GSK1120212 in the parent study due to toxicity or disease progression.
- 2. Current use of a prohibitive medication(s) as listed in Section 6.2.
Inclusion and exclusion criteria
Inclusion criteria:
- 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. 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. 7. Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study. 8. 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.
Exclusion criteria:
- 1. Permanent discontinuation of GSK1120212 in the parent study due to toxicity or disease progression. 2. 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. 3. 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. 4. Bazett-corrected QT (QTcB) interval ≥501 msec at the time of transition to this study 5. 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. 6. Nursing female. 7. 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. -
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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