Trametinib With GSK2141795 in BRAF Wild-type Melanoma
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ClinicalTrials.gov Identifier: NCT01941927 |
Recruitment Status :
Completed
First Posted : September 13, 2013
Results First Posted : February 12, 2020
Last Update Posted : February 12, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | August 30, 2013 | ||||
First Posted Date ICMJE | September 13, 2013 | ||||
Results First Submitted Date ICMJE | February 28, 2018 | ||||
Results First Posted Date ICMJE | February 12, 2020 | ||||
Last Update Posted Date | February 12, 2020 | ||||
Actual Study Start Date ICMJE | September 10, 2013 | ||||
Actual Primary Completion Date | October 14, 2014 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) [ Time Frame: Up to 2 years from beginning of therapy ] Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response These participants will have their response classified according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) method, where the baseline target lesion sum of longest diameter (LD) will be used as reference by which to characterize the objective tumor response. An objective response is defined as an overall response of complete response (CR), partial response (PR), or stable disease (SD) with a confirmatory scan or evaluation at time of final disease response determination.
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Original Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) in patients with either mutated NRAS or wild-type NRAS/wild-type BRAF melanoma treated with the combination of trametinib and GSK 2141795 [ Time Frame: Up to 2 years ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | Trametinib With GSK2141795 in BRAF Wild-type Melanoma | ||||
Official Title ICMJE | Phase II Clinical Trial of the MEK Inhibitor Trametinib With the AKT Inhibitor GSK2141795 in BRAF Wild-type Melanoma | ||||
Brief Summary | This is a multicenter phase II clinical study of trametinib in combination with GSK2141795 in patients with BRAF wild-type mutation melanoma. All patients will receive continuous dosing of trametinib (2 mg) in combination with GSK2141795 (25 mg) oral daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity. Imaging (CT or MRI) will be performed within 7 days prior to day 1 of Odd Cycles, starting with Cycle 3. Patients may continue treatment with trametinib in combination with GSK2141795 on trial until disease progression or the development of unacceptable toxicity that does not improve with maximal supportive care or dose reduction per protocol. Treatment-associated adverse events will be assessed based on clinical and laboratory findings using the Common Toxicity Criteria for Adverse Events, version 4.0. Adverse event (AE) assessments will be performed every week through cycle 3 day 1, and on day 1 for every cycle thereafter. AEs and Serious adverse events (SAE)s will be monitored by UCSF's Data Safety Monitoring Committee. Safety assessments will include medical history, physical examination, Complete Blood Count (CBC) with differential, chemistries panel, thyroid function and pregnancy tests, ECGs, and ophthalmology evaluations. Screening assessments will also include a transthoracic echocardiogram or multiple-gated acquisition (MUGA) scan, and brain imaging. It is estimated that 48 patients will complete the study. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Trametinib, GSK2141795
Trametinib (GSK1120212)
GSK2141795
Interventions:
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Publications * | Algazi AP, Esteve-Puig R, Nosrati A, Hinds B, Hobbs-Muthukumar A, Nandoskar P, Ortiz-Urda S, Chapman PB, Daud A. Dual MEK/AKT inhibition with trametinib and GSK2141795 does not yield clinical benefit in metastatic NRAS-mutant and wild-type melanoma. Pigment Cell Melanoma Res. 2018 Jan;31(1):110-114. doi: 10.1111/pcmr.12644. Epub 2017 Nov 2. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE |
40 | ||||
Actual Study Completion Date ICMJE | May 3, 2017 | ||||
Actual Primary Completion Date | October 14, 2014 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01941927 | ||||
Other Study ID Numbers ICMJE | 13855 NCI-2013-01849 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Adil Daud, University of California, San Francisco | ||||
Study Sponsor ICMJE | Adil Daud | ||||
Collaborators ICMJE | National Comprehensive Cancer Network | ||||
Investigators ICMJE |
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PRS Account | University of California, San Francisco | ||||
Verification Date | January 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |