CancerPhase 2NCT01376310
GSK1120212 Rollover Study
A Phase 2 study testing GSK1120212, Docetaxel + GSK1120212 and Erlotinib + GSK1120212 in people with Cancer, run by Novartis Pharmaceuticals at 19 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- GSK1120212, Docetaxel + GSK1120212 and Erlotinib + GSK1120212
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 2 Nov 2010to 18 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
United States13 sites
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Goodyear, Arizona, 85338
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
New Haven, Connecticut, 06510
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
Novartis Investigative Site
Sacramento, California, 95817
Novartis Investigative Site
Salt Lake City, Utah, 84112
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Sarasota, Florida, 34232
Novartis Investigative Site
Scottsdale, Arizona, 85259
Novartis Investigative Site
Tacoma, Washington, 98405
France2 sites
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Villejuif, 94805
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- GSK1120212, Docetaxel + GSK1120212, Erlotinib + GSK1120212, Pemetrexed + GSK1120212, Carboplatin + GSK1120212
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1120212Drug
up to 2 mg/day
Docetaxel + GSK1120212Drug
Also called Taxotere
dose as defined in the dose escalation protocol.
Erlotinib + GSK1120212Drug
Also called Tarceva
dose as defined in the dose escalation protocol.
Pemetrexed + GSK1120212Drug
Also called Alimta
dose as defined in the dose escalation protocol
Carboplatin + GSK1120212Drug
Also called Paraplatin
dose as defined in the dose escalation protocol
Nab-paclitaxel + GSK1120212Drug
Also called Abraxane
dose as defined in the dose escalation protocol
Gemcitabine + GSK1120212Drug
Also called Gemzar
dose as defined in the dose escalation protocol
Everolimus + GSK1120212Drug
Also called Afinitor
dose as defined in the dose escalation protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Subjects on GSK1120212 Monotherapy who have been treated less than 24 weeks in their parent study. Receives: Drug: GSK1120212 |
| Cohort B | Experimental | 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. Receives: Drug: GSK1120212; Drug: Docetaxel + GSK1120212; Drug: Erlotinib + GSK1120212; Drug: Pemetrexed + GSK1120212; Drug: Carboplatin + GSK1120212; Drug: Nab-paclitaxel + GSK1120212; Drug: Gemcitabine + GSK1120212; Drug: Everolimus + GSK1120212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of participants with adverse events as a measure of safety and tolerability
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study start2 Nov 2010
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376310
- Sponsor's protocol ID
- 114375
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2011
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia
- ClinicalTrials.gov ID
- NCT01376310
- Acronym / sponsor ID
- 114375
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2010 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: GSK1120212Subjects on GSK1120212 Monotherapy who have been treated less than 24 weeks in their parent study. |
| Cohort B | Experimental | Drug: GSK1120212, Drug: Docetaxel + GSK1120212, Drug: Erlotinib + GSK1120212, Drug: Pemetrexed + GSK1120212, Drug: Carboplatin + GSK1120212, Drug: Nab-paclitaxel + GSK1120212, Drug: Gemcitabine + GSK1120212, Drug: Everolimus + GSK1120212Subjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1120212up to 2 mg/day | Drug | Cohort A, Cohort B |
| Docetaxel + GSK1120212Also: Taxoteredose as defined in the dose escalation protocol. | Drug | Cohort B |
| Erlotinib + GSK1120212Also: Tarcevadose as defined in the dose escalation protocol. | Drug | Cohort B |
| Pemetrexed + GSK1120212Also: Alimtadose as defined in the dose escalation protocol | Drug | Cohort B |
| Carboplatin + GSK1120212Also: Paraplatindose as defined in the dose escalation protocol | Drug | Cohort B |
| Nab-paclitaxel + GSK1120212Also: Abraxanedose as defined in the dose escalation protocol | Drug | Cohort B |
| Gemcitabine + GSK1120212Also: Gemzardose as defined in the dose escalation protocol | Drug | Cohort B |
| Everolimus + GSK1120212Also: Afinitordose as defined in the dose escalation protocol | Drug | Cohort B |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
19 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK1120212, Docetaxel + GSK1120212 and Erlotinib + GSK1120212 in people with Cancer, run by Novartis Pharmaceuticals at 19 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, France, Canada, Netherlands, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.