GNA11 Mutation-positive Metastatic MelanomaPhase 2NCT01328106
Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma
A Phase 2 study testing GSK1120212 in people with GNA11 Mutation-positive Metastatic Melanoma and GNAQ Mutation-positive Metastatic Melanoma, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GNA11 Mutation-positive Metastatic Melanoma, GNAQ Mutation-positive Metastatic Melanoma, Cancer
- What is being tested?
- GSK1120212
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.
- Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.
- The patient has a radiographically measurable tumor.
- ECOG performance status 0, 1, or 2.
- The patient is able to swallow and retain oral medication.
- Life expectancy of at least 4 months.
Show all 10Show fewer
- Toxicities from previous anti-cancer therapy (except alopecia) are recovered (Grade 1 or less) at the time of enrollment.
- The patient has adequate organ and bone marrow function.
- Sexually active patients must use medically acceptable methods of contraception during the course of the study.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening.
Who cannot join
- The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.
- The patient has received experimental therapy within 21 days of starting study drug.
- The patient has received nitrosourea or mitomycin C within 42 days of starting study drug.
- The patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug.
- The patient is currently receiving anticoagulation therapy that is not well controlled.
- Ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma.
Show all 14Show fewer
- History of retinal vein occlusion or central serous retinopathy.
- Current severe, uncontrolled systemic disease.
- History of leptomeningeal disease or spinal cord compression secondary to metastasis.
- Brain metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 3 months without steroid use or on a stable dose of steroids for at least 1 month prior to starting study drug. Stability of brain metastases must be confirmed with imaging.
- The patient has a concurrent, active hematological malignancy or other solid tumor malignancy.
- History of clinically significant cardiac or pulmonary dysfunction.
- Allergy or hypersensitivity to components of the GSK1120212 formulation.
- The patient is pregnant or breastfeeding.
About this study
Official title: A Single-Arm, Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in Subjects With Metastatic Uveal Melanoma or With Mutation-Positive GNAQ or GNA11 Metastatic Melanoma
The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma.
- Conditions
- GNA11 Mutation-positive Metastatic Melanoma, GNAQ Mutation-positive Metastatic Melanoma, Cancer, Metastatic Uveal Melanoma
- Being tested
- GSK1120212
- Medical subject headings
- Neoplasms, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1120212Drug
Repeating oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: GSK1120212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate as assessed by RECIST v1.1
Measured: At least 12 weeks after initiating study treatment
Secondary outcomes (2)
Duration of response, progression free survival, overall survival
Measured: Through study completion or early study discontinuation
Safety, tolerability, and population pharmacokinetic parameters
Measured: Through study completion or early study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionAug 2011 (estimated)
- Study completionMay 2012 (estimated)
Why it stopped: The study was cancelled by the sponsor prior to initiation of study enrollment. No subjects were accrued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GNA11 Mutation-positive Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328106
- Sponsor's protocol ID
- 114091
- Status last verified
- Dec 2017
- First submitted
- 18 Mar 2010
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in Subjects With Metastatic Uveal Melanoma or With Mutation-Positive GNAQ or GNA11 Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01328106
- Acronym / sponsor ID
- 114091
- Conditions
- GNA11 Mutation-positive Metastatic Melanoma, GNAQ Mutation-positive Metastatic Melanoma, Cancer, Metastatic Uveal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was cancelled by the sponsor prior to initiation of study enrollment. No subjects were accrued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GSK1120212 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.
- Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.
- The patient has a radiographically measurable tumor.
- ECOG performance status 0, 1, or 2.
- The patient is able to swallow and retain oral medication.
Key exclusion criteria (14 listed)
- The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.
- The patient has received experimental therapy within 21 days of starting study drug.
- The patient has received nitrosourea or mitomycin C within 42 days of starting study drug.
- The patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug.
- The patient is currently receiving anticoagulation therapy that is not well controlled.
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 |
|---|---|---|
| GSK1120212Repeating oral dose | Drug | 1 |
Primary outcome
Objective response rate as assessed by RECIST v1.1
Time frame: At least 12 weeks after initiating study treatment
2 secondary outcomes
Duration of response, progression free survival, overall survival
Time frame: Through study completion or early study discontinuation
Safety, tolerability, and population pharmacokinetic parameters
Time frame: Through study completion or early study discontinuation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK1120212 in people with GNA11 Mutation-positive Metastatic Melanoma and GNAQ Mutation-positive Metastatic Melanoma, run by GlaxoSmithKline.
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 10 inclusion and 14 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: withdrawn, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective response rate as assessed by RECIST v1.1 (time frame: At least 12 weeks after initiating study treatment). 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 12 Dec 2017.