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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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Melanoma |
Interventions |
Drug: Trametinib (GSK1120212) Drug: GSK2141795 |
Enrollment | 20 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | NRAS Wildtype | NRAS Mutant |
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Patients without NRAS (neuroblastoma RAS viral oncogene homolog) exon 1 and 2 mutations | Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing |
Period Title: Overall Study | ||
Started | 10 | 10 |
Completed | 10 | 10 |
Not Completed | 0 | 0 |
Arm/Group Title | NRAS Wildtype | NRAS Mutant | Total | |
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Patients without NRAS exon 1 and 2 mutations | Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation sequencing | Total of all reporting groups | |
Overall Number of Baseline Participants | 10 | 10 | 20 | |
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Patients with NRAS exon 1 and 2 mutations (NRAS mutant) identified by Sanger sequencing or exon-capture next-generation equencing and patients without these mutations (wild-type (WT)). The sample size for each arm was based on a Simon 2-stage stage design.
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Age, Customized
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 10 participants | 10 participants | 20 participants | |
59.3
(40 to 86)
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56.8
(19 to 67)
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58.5
(19 to 86)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | 10 participants | 20 participants | |
Female |
2 20.0%
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3 30.0%
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5 25.0%
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Male |
8 80.0%
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7 70.0%
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15 75.0%
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Eastern Cooperative Oncology Group (ECOG) status: 0
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 10 participants | 10 participants | 20 participants |
ECOG status 0 |
6 60.0%
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2 20.0%
|
8 40.0%
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ECOG status 1 |
4 40.0%
|
8 80.0%
|
12 60.0%
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ECOG status 2 |
0 0.0%
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0 0.0%
|
0 0.0%
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[1]
Measure Description:
Participants were rated using the ECOG Performance Status Scale. Status had to be 0 to 2 in order to be eligible for the study. Grade 0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction Grade 1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work) Grade 2: In bed < 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours |
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Stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 10 participants | 10 participants | 20 participants |
M1a |
0 0.0%
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2 20.0%
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2 10.0%
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M1b |
0 0.0%
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2 20.0%
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2 10.0%
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M1c |
10 100.0%
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6 60.0%
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16 80.0%
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[1]
Measure Description:
Histological confirmation of Malignant Melanoma using the American Joint Committee on Cancer (AJCC) tumor/node/metastasis (TNM) classification and staging system. M1a: Metastases to skin, soft tissue (including muscle), and/or nonregional lymph nodes M1b: Lung metastasis, with or without M1a involvement M1c: Distant metastasis to non-central nervous system (CNS) visceral sites with or without M1a or M1b involvement |
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Lactate Dehydrogenase (LDH) level
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 10 participants | 10 participants | 20 participants |
LDH normal |
2 20.0%
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2 20.0%
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4 20.0%
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|
LDH elevated |
8 80.0%
|
8 80.0%
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16 80.0%
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Genotype
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 10 participants | 10 participants | 20 participants |
Genotype NRAS Q61H |
0 0.0%
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1 10.0%
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1 5.0%
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|
Genotype NRAS Q61K |
0 0.0%
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3 30.0%
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3 15.0%
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Genotype NRAS Q61L |
0 0.0%
|
1 10.0%
|
1 5.0%
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Genotype NRAS Q61R |
0 0.0%
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5 50.0%
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5 25.0%
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BRAF Wild Type (WT) /NRAS WT |
10 100.0%
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0 0.0%
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10 50.0%
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Subtype
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 10 participants | 10 participants | 20 participants |
Cutaneous |
6 60.0%
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0 0.0%
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6 30.0%
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Mucosal |
0 0.0%
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8 80.0%
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8 40.0%
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Acral |
1 10.0%
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2 20.0%
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3 15.0%
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Uveal |
3 30.0%
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0 0.0%
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3 15.0%
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Name/Title: | Adil Daud, MD |
Organization: | University of California, San Francisco |
Phone: | (415) 353-7392 |
EMail: | Adil.Daud@ucsf.edu |
Responsible Party: | Adil Daud, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01941927 |
Other Study ID Numbers: |
13855 NCI-2013-01849 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) ) |
First Submitted: | August 30, 2013 |
First Posted: | September 13, 2013 |
Results First Submitted: | February 28, 2018 |
Results First Posted: | February 12, 2020 |
Last Update Posted: | February 12, 2020 |