GSK1120212 Rollover Study

MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Drug: GSK1120212; Drug: Docetaxel + GSK1120212; Drug: Erlotinib + GSK1120212; Drug: Pemetrexed + GSK1120212; Drug: Carboplatin + GSK1120212; Drug: Nab-paclitaxel + GSK1120212; Drug: Gemcitabine + GSK1120212; Drug: Everolimus + GSK1120212

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Novartis Investigative Site
• France
  • Toulouse Cedex 9, France, 31059
    • Novartis Investigative Site
  • Villejuif Cedex, France, 94805
    • Novartis Investigative Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Novartis Investigative Site
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Novartis Investigative Site
• Taiwan
  • Taipei, Taiwan
    • Novartis Investigative Site
• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Novartis Investigative Site
    • Scottsdale, Arizona, United States, 85259
      • Novartis Investigative Site
  • California
    • Sacramento, California, United States, 95817
      • Novartis Investigative Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Novartis Investigative Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Novartis Investigative Site
  • Florida
    • Sarasota, Florida, United States, 34232
      • Novartis Investigative Site
  • New York
    • New York, New York, United States, 10016
      • Novartis Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Novartis Investigative Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Novartis Investigative Site
  • Texas
    • Houston, Texas, United States, 77030
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Novartis Investigative Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Taxotere; Drug: Erlotinib + GSK1120212; dose as defined in the dose escalation protocol.; Other Names: Tarceva; Drug: Pemetrexed + GSK1120212; dose as defined in the dose escalation protocol; Other Names: Alimta; Drug: Carboplatin + GSK1120212; dose as defined in the dose escalation protocol; Other Names: Paraplatin; Drug: Nab-paclitaxel + GSK1120212; dose as defined in the dose escalation protocol; Other Names: Abraxane; Drug: Gemcitabine + GSK1120212; dose as defined in the dose escalation protocol; Other Names: Gemzar; Drug: Everolimus + GSK1120212; dose as defined in the dose escalation protocol; Other Names: Afinitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Number of participants with adverse events as a measure of safety and tolerability	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.

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2010
• Primary Completion (ACTUAL): January 18, 2018
• Study Completion (ACTUAL): January 18, 2018

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (ESTIMATE): June 20, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 17, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Folic Acid Antagonists; Gemcitabine; Docetaxel; Carboplatin; Paclitaxel; Erlotinib Hydrochloride; Pemetrexed; Everolimus; Trametinib
• Other Study ID Numbers: 114375

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No