GSK1120212 Rollover Study

Stopped early · Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT01376310

Run by

Novartis Pharmaceuticals

People needed

159

Starts

2010-11-02

Expected to finish

2018-01-18

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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