Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
159 participants
INTERVENTIONAL
2010-11-02
2018-01-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.
NCT01248858
Study to Investigate AKT Inhibitor GSK690693 in Subjects With Relapsed or Refractory Hematologic Malignancies
NCT00666081
Study to Investigate the Absorption, Distribution, Metabolism and Elimination of [14C]GSK1120212
NCT01387204
A Study of the GSK MEK Inhibitor GSK1120212 and Everolimus in Cancer Subjects
NCT00955773
Trial of GSK1120212 and GSK1120212 in Combination With GEM in Japanese Subjects With Solid Tumors
NCT01324258
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
Subjects on GSK1120212 Monotherapy who have been treated less than 24 weeks in their parent study.
GSK1120212
up to 2 mg/day
Cohort B
Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
GSK1120212
up to 2 mg/day
Docetaxel + GSK1120212
dose as defined in the dose escalation protocol.
Erlotinib + GSK1120212
dose as defined in the dose escalation protocol.
Pemetrexed + GSK1120212
dose as defined in the dose escalation protocol
Carboplatin + GSK1120212
dose as defined in the dose escalation protocol
Nab-paclitaxel + GSK1120212
dose as defined in the dose escalation protocol
Gemcitabine + GSK1120212
dose as defined in the dose escalation protocol
Everolimus + GSK1120212
dose as defined in the dose escalation protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GSK1120212
up to 2 mg/day
Docetaxel + GSK1120212
dose as defined in the dose escalation protocol.
Erlotinib + GSK1120212
dose as defined in the dose escalation protocol.
Pemetrexed + GSK1120212
dose as defined in the dose escalation protocol
Carboplatin + GSK1120212
dose as defined in the dose escalation protocol
Nab-paclitaxel + GSK1120212
dose as defined in the dose escalation protocol
Gemcitabine + GSK1120212
dose as defined in the dose escalation protocol
Everolimus + GSK1120212
dose as defined in the dose escalation protocol
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
\-
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Goodyear, Arizona, United States
Novartis Investigative Site
Scottsdale, Arizona, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
Aurora, Colorado, United States
Novartis Investigative Site
New Haven, Connecticut, United States
Novartis Investigative Site
Sarasota, Florida, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Tacoma, Washington, United States
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
114375
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.