GSK1120212 Rollover Study
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis
ClinicalTrials.gov Identifier:
NCT01376310
First Posted: June 20, 2011
Last Update Posted: September 27, 2017
Information provided by (Responsible Party):
Novartis
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Purpose
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 | Intervention | 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 |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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
| Estimated Enrollment: | 250 |
| Actual Study Start Date: | March 28, 2011 |
| Estimated Study Completion Date: | November 30, 2017 |
| Estimated Primary Completion Date: | November 30, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility
Information from the National Library of Medicine
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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:
- 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.
-
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
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
Show 22 Study Locations
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01376310 History of Changes |
| Other Study ID Numbers: |
114375 |
| First Submitted: | February 3, 2011 |
| First Posted: | June 20, 2011 |
| Last Update Posted: | September 27, 2017 |
| Last Verified: | September 2017 |
| 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 |