GSK1120212 Rollover Study

Study Description

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Brief Summary:

This is an open-label study which will permit subjects with solid tumors or leukemia, who are currently 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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	250 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 and Leukemia
Actual Study Start Date :	March 28, 2011
Estimated Primary Completion Date :	August 30, 2018
Estimated Study Completion Date :	August 30, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Cohort A; Subjects on GSK1120212 Monotherapy and 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

Outcome Measures

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Primary Outcome Measures :

1. Number of participants with adverse events [ Time Frame: From date of transition into this Rollover study until 28 days following the last dose. Subjects may continue to receive study medication until disease progression, death, or unacceptable adverse event: there is no time limit for this outcome measure. ]
   as a measure of safety and tolerability

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 22 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01376310 History of Changes
Other Study ID Numbers:	114375
First Posted:	June 20, 2011
Last Update Posted:	January 12, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Gemcitabine; Pemetrexed; Trametinib; Everolimus; Carboplatin; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents	Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Protein Kinase Inhibitors