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GSK1120212 Rollover Study

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
Recruitment Status : Terminated (Company Decision)
First Posted : June 20, 2011
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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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
Experimental: Cohort A
Subjects on GSK1120212 Monotherapy who have been treated less than 24 weeks in their parent study.
Drug: GSK1120212
up to 2 mg/day

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.
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 :
  1. 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



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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:

  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.

    -


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
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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] February 27, 2014
Statistical Analysis Plan  [PDF] December 14, 2016

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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

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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