GSK1120212 Rollover Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01376310 |
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Recruitment Status :
Terminated
(Company Decision)
First Posted : June 20, 2011
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
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Brief Summary:
This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Drug: GSK1120212 Drug: Docetaxel + GSK1120212 Drug: Erlotinib + GSK1120212 Drug: Pemetrexed + GSK1120212 Drug: Carboplatin + GSK1120212 Drug: Nab-paclitaxel + GSK1120212 Drug: Gemcitabine + GSK1120212 Drug: Everolimus + GSK1120212 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 159 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia |
| Actual Study Start Date : | November 2, 2010 |
| Actual Primary Completion Date : | January 18, 2018 |
| Actual Study Completion Date : | January 18, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Trametinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort A
Subjects on GSK1120212 Monotherapy who have been treated less than 24 weeks in their parent study.
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Drug: GSK1120212
up to 2 mg/day |
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Experimental: 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.
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Drug: GSK1120212
up to 2 mg/day Drug: Docetaxel + GSK1120212 dose as defined in the dose escalation protocol.
Other Name: Taxotere Drug: Erlotinib + GSK1120212 dose as defined in the dose escalation protocol.
Other Name: Tarceva Drug: Pemetrexed + GSK1120212 dose as defined in the dose escalation protocol
Other Name: Alimta Drug: Carboplatin + GSK1120212 dose as defined in the dose escalation protocol
Other Name: Paraplatin Drug: Nab-paclitaxel + GSK1120212 dose as defined in the dose escalation protocol
Other Name: Abraxane Drug: Gemcitabine + GSK1120212 dose as defined in the dose escalation protocol
Other Name: Gemzar Drug: Everolimus + GSK1120212 dose as defined in the dose escalation protocol
Other Name: Afinitor |
Primary Outcome Measures :
- Number of Participants With Adverse Events [ Time Frame: Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months. ]Number of participants with adverse events as a measure of safety and tolerability
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has provided signed informed consent for this study.
- Has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form.
- Is currently participating in GSK1120212 study and is receiving treatment with GSK1120212.
- 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.
- 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.
- 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.
- Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
- 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:
- Permanent discontinuation of GSK1120212 in the parent study due to toxicity or disease progression.
- 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.
- 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.
- Bazett-corrected QT (QTcB) interval ≥501 msec at the time of transition to this study
- 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.
- Nursing female.
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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.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376310
Locations
| United States, Arizona | |
| Novartis Investigative Site | |
| Goodyear, Arizona, United States, 85338 | |
| Novartis Investigative Site | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Novartis Investigative Site | |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| Novartis Investigative Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Novartis Investigative Site | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Novartis Investigative Site | |
| Sarasota, Florida, United States, 34232 | |
| United States, New York | |
| Novartis Investigative Site | |
| New York, New York, United States, 10016 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Novartis Investigative Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Novartis Investigative Site | |
| Houston, Texas, United States, 77030 | |
| Novartis Investigative Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Novartis Investigative Site | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Washington | |
| Novartis Investigative Site | |
| Tacoma, Washington, United States, 98405 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| France | |
| Novartis Investigative Site | |
| Toulouse Cedex 9, France, 31059 | |
| Novartis Investigative Site | |
| Villejuif Cedex, France, 94805 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Netherlands | |
| Novartis Investigative Site | |
| Groningen, Netherlands, 9713 GZ | |
| Taiwan | |
| Novartis Investigative Site | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Study Documents (Full-Text)
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol [PDF] February 27, 2014
Statistical Analysis Plan [PDF] December 14, 2016
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01376310 |
| Other Study ID Numbers: |
114375 |
| First Posted: | June 20, 2011 Key Record Dates |
| Results First Posted: | February 19, 2019 |
| Last Update Posted: | February 19, 2019 |
| Last Verified: | February 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Gemcitabine Paclitaxel Docetaxel Carboplatin Erlotinib Hydrochloride Everolimus Pemetrexed Trametinib Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Protein Kinase Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |