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Trial record 1 of 1 for:    NCT02094872
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Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic

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ClinicalTrials.gov Identifier: NCT02094872
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Melanoma
Stage IIIA Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Interventions Other: cytology specimen collection procedure
Drug: MEK 162 therapy or molecularly targeted therapy
Procedure: therapeutic procedure
Other: laboratory biomarker analysis
Other: quality-of-life assessment
Enrollment 49
Recruitment Details Based on the initial 23 patients enrolled on this study who underwent molecular profiling and tumor board evaluation, 20 were assigned MEK162 by the tumor board. Patients not assigned MEK162 still received their assigned treatment, but were not considered evaluable for the primary endpoint.
Pre-assignment Details  
Arm/Group Title Arm I (Molecularly Targeted Therapy)
Hide Arm/Group Description

Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

cytology specimen collection procedure: Undergo collection of tissue and blood samples

MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy

therapeutic procedure

laboratory biomarker analysis: Correlative studies

quality-of-life assessment: Ancillary studies

Period Title: Overall Study
Started 49
Received Biopsy 37
Received Tumor-board Recommendation 36 [1]
Received Targeted Therapy 20
Received Standard of Care 9 [2]
Patients Treated With MEK162 [3] 20
Completed 20
Not Completed 29
[1]
1 individual withdrew consent after biopsy.
[2]
7 standard-of-care patients crossed-over and received targeted therapy.
[3]
Total patients treated with MEK162 for final primary endpoint (following study redesign)
Arm/Group Title Arm I (Molecularly Targeted Therapy)
Hide Arm/Group Description

Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

cytology specimen collection procedure: Undergo collection of tissue and blood samples

MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy

therapeutic procedure

laboratory biomarker analysis: Correlative studies

quality-of-life assessment: Ancillary studies

Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
30-39
1
   2.0%
40-49
6
  12.2%
50-59
10
  20.4%
60-69
13
  26.5%
70-79
15
  30.6%
80-89
4
   8.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
23
  46.9%
Male
26
  53.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
American Indian or Alaskan Native
0
   0.0%
Asian or Pacific Islander
0
   0.0%
Black, not of Hispanic Origin
2
   4.1%
Hispanic
6
  12.2%
White, not of Hispanic Origin
43
  87.8%
Other/
4
   8.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants
49
1.Primary Outcome
Title Best Overall Response Rate (BORR)
Hide Description The best overall response rate (BORR) was assessed up to 1 year.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Molecularly Targeted Therapy)
Hide Arm/Group Description:

Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

cytology specimen collection procedure: Undergo collection of tissue and blood samples

MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy

therapeutic procedure

laboratory biomarker analysis: Correlative studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Progressive Disease
2
  10.0%
Stable Disease
17
  85.0%
Partial Response
1
   5.0%
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description A log rank test will be performed for the comparison between the two groups.
Time Frame From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Given the lack of response in this study and the decision to terminate it early, no data for PFS data were collected or analyzed. In addition, with the study amendment removing the second arm, this analysis would not have been possible to conduct.
Arm/Group Title Arm I (Molecularly Targeted Therapy)
Hide Arm/Group Description:

Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

cytology specimen collection procedure: Undergo collection of tissue and blood samples

MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy

therapeutic procedure

laboratory biomarker analysis: Correlative studies

quality-of-life assessment: Ancillary studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Molecularly Targeted Therapy)
Hide Arm/Group Description

Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

cytology specimen collection procedure: Undergo collection of tissue and blood samples

MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy

therapeutic procedure

laboratory biomarker analysis: Correlative studies

quality-of-life assessment: Ancillary studies

All-Cause Mortality
Arm I (Molecularly Targeted Therapy)
Affected / at Risk (%)
Total   5/49 (10.20%) 
Hide Serious Adverse Events
Arm I (Molecularly Targeted Therapy)
Affected / at Risk (%)
Total   48/49 (97.96%) 
Blood and lymphatic system disorders   
Hospitalized for anemia   1/49 (2.04%) 
Thrombocytopenia   1/49 (2.04%) 
Gastrointestinal disorders   
Hospitalized for Nausea and vomiting   1/49 (2.04%) 
Anemia due to gastric hemorrhage   1/49 (2.04%) 
Hospitalized for abdominal and back pain   1/49 (2.04%) 
General disorders   
Generalized Weakness   1/49 (2.04%) 
Fatigue   2/49 (4.08%) 
Weakness and fatigue   1/49 (2.04%) 
Hospitalized for generalized weakness   1/49 (2.04%) 
Generalized weakness requiring hospitalization; outcome death   1/49 (2.04%) 
Hepatobiliary disorders   
Hepatic Failure (patient never received drug)   1/49 (2.04%) 
Immune system disorders   
Anaphylactic reaction to taxol, hospitalized   1/49 (2.04%) 
Allergic reaction to Augmentin; Acute kidney Injury (patient never received drug)   1/49 (2.04%) 
Infections and infestations   
Hospitalized for UTI   1/49 (2.04%) 
Enterocolitis infectious (Clostridium difficile)   1/49 (2.04%) 
Hospitalized for fever   1/49 (2.04%) 
Strep B sepsis   1/49 (2.04%) 
Metabolism and nutrition disorders   
Hyponatremia   4/49 (8.16%) 
Hypochloridemia   1/49 (2.04%) 
Musculoskeletal and connective tissue disorders   
Dropped Head Syndrome   1/49 (2.04%) 
Ocular muscle weakness   1/49 (2.04%) 
Hospitalized for back pain   1/49 (2.04%) 
Nervous system disorders   
Hospitalized for chronic intractable pain   1/49 (2.04%) 
Headache   1/49 (2.04%) 
Hospitalization for neurological symptoms: brain metastasis   1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Hospitalized for pneumonitis   1/49 (2.04%) 
Hospitalized for pneumonia, sepsis, outcome death   1/49 (2.04%) 
Skin and subcutaneous tissue disorders   
Acneiform rash   1/49 (2.04%) 
Elevated alkaline phosphatase   1/49 (2.04%) 
Elevated aspartate aminotransferase   3/49 (6.12%) 
Elevated alanine aminotransferase   1/49 (2.04%) 
Transaminitis   1/49 (2.04%) 
Creatine phosphokinase elevation   2/49 (4.08%) 
Uric acid elevations   1/49 (2.04%) 
Surgical and medical procedures   
Radical resection of malignant soft tissue tumor (melanoma) on back   1/49 (2.04%) 
Vascular disorders   
Hospitalized for hypotension related to adrenal insufficiency   1/49 (2.04%) 
Hospitalized for hypotension   1/49 (2.04%) 
Hypertension   1/49 (2.04%) 
Hospitalized for pulmonary embolism   3/49 (6.12%) 
Hypotensive, AKI (patient never received drug)   1/49 (2.04%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Molecularly Targeted Therapy)
Affected / at Risk (%)
Total   32/49 (65.31%) 
Blood and lymphatic system disorders   
Anemia   11/49 (22.45%) 
Blood and lymphatic system disorders - Other   5/49 (10.20%) 
Leukocytosis   1/49 (2.04%) 
Cardiac disorders   
Cardiac disorders - Other   2/49 (4.08%) 
Sinus bradycardia   1/49 (2.04%) 
Ear and labyrinth disorders   
Hearing impaired   1/49 (2.04%) 
Tinnitus   1/49 (2.04%) 
Endocrine disorders   
Adrenal insufficiency   1/49 (2.04%) 
Endocrine disorders - Other   1/49 (2.04%) 
Hypothyroidism   3/49 (6.12%) 
Eye disorders   
Blurred vision   2/49 (4.08%) 
Cataract   1/49 (2.04%) 
Conjunctivitis   1/49 (2.04%) 
Eye disorders - Other   6/49 (12.24%) 
Glaucoma   1/49 (2.04%) 
retinal detachment   1/49 (2.04%) 
watering eyes   1/49 (2.04%) 
Gastrointestinal disorders   
Abdominal pain   11/49 (22.45%) 
Ascites   1/49 (2.04%) 
Bloating   1/49 (2.04%) 
Cheilitis   1/49 (2.04%) 
Constipation   14/49 (28.57%) 
Diarrhea   19/49 (38.78%) 
Dry mouth   4/49 (8.16%) 
Dyspepsia   1/49 (2.04%) 
Dysphagia   1/49 (2.04%) 
Esophagitis   1/49 (2.04%) 
Fecal incontinence   1/49 (2.04%) 
Flatulence   2/49 (4.08%) 
Gastrointestinal disorders - Other, specify   12/49 (24.49%) 
Mucositis oral   3/49 (6.12%) 
Nausea   22/49 (44.90%) 
Oral hemorrhage   1/49 (2.04%) 
Oral pain   1/49 (2.04%) 
Rectal hemorrhage   1/49 (2.04%) 
Stomach pain   1/49 (2.04%) 
Vomiting   12/49 (24.49%) 
Lower gastrointestinal hemorrhage   1/49 (2.04%) 
Anal hemorrhage   1/49 (2.04%) 
Gastroesophageal reflux disease   2/49 (4.08%) 
General disorders   
Chills   6/49 (12.24%) 
Edema face   2/49 (4.08%) 
Fatigue   25/49 (51.02%) 
Fever   4/49 (8.16%) 
Flu like symptoms   3/49 (6.12%) 
Gait disturbance   2/49 (4.08%) 
General disorders and administration site conditions - Other, specify   12/49 (24.49%) 
Pain   1/49 (2.04%) 
Edema limbs   15/49 (30.61%) 
Infusion related reaction   1/49 (2.04%) 
Localized edema   2/49 (4.08%) 
Non-cardiac chest pain   1/49 (2.04%) 
Immune system disorders   
Anaphylaxis   1/49 (2.04%) 
Infections and infestations   
Infections and infestations - Other, specify   1/49 (2.04%) 
Paronychia   1/49 (2.04%) 
Upper respiratory infection   3/49 (6.12%) 
Urinary tract infection   3/49 (6.12%) 
Wound infection   1/49 (2.04%) 
Mucosal infection   2/49 (4.08%) 
Injury, poisoning and procedural complications   
Bruising   1/49 (2.04%) 
Fall   1/49 (2.04%) 
Fracture   1/49 (2.04%) 
Injury, poisoning and procedural complications - Other, specify   2/49 (4.08%) 
Postoperative hemorrhage   1/49 (2.04%) 
Investigations   
Alanine aminotransferase increased   7/49 (14.29%) 
Alkaline phosphatase increased   3/49 (6.12%) 
Aspartate aminotransferase increased   12/49 (24.49%) 
Blood bilirubin increased   2/49 (4.08%) 
Cardiac troponin I increased   1/49 (2.04%) 
Cardiac troponin T increased   1/49 (2.04%) 
CPK increased   10/49 (20.41%) 
Creatinine increased   6/49 (12.24%) 
INR increased   1/49 (2.04%) 
Investigations - Other, specify   4/49 (8.16%) 
Lymphocyte count decreased   1/49 (2.04%) 
Neutrophil count decreased   1/49 (2.04%) 
Platelet count decreased   4/49 (8.16%) 
Weight gain   3/49 (6.12%) 
Weight loss   3/49 (6.12%) 
Hemoglobin increased   1/49 (2.04%) 
Metabolism and nutrition disorders   
Anorexia   9/49 (18.37%) 
Dehydration   4/49 (8.16%) 
Hypercalcemia   1/49 (2.04%) 
Hyperglycemia   2/49 (4.08%) 
Hyperkalemia   1/49 (2.04%) 
Hyperuricemia   1/49 (2.04%) 
Hypoalbuminemia   6/49 (12.24%) 
Hypoglycemia   2/49 (4.08%) 
Hypokalemia   4/49 (8.16%) 
Hypomagnesemia   4/49 (8.16%) 
Hyponatremia   7/49 (14.29%) 
Hypophosphatemia   2/49 (4.08%) 
Metabolism and nutrition disorders - Other   2/49 (4.08%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   3/49 (6.12%) 
Arthritis   1/49 (2.04%) 
Back pain   6/49 (12.24%) 
Bone pain   2/49 (4.08%) 
Flank pain   1/49 (2.04%) 
Musculoskeletal and connective tissue disorder - Other, specify   9/49 (18.37%) 
Myalgia   3/49 (6.12%) 
Neck pain   1/49 (2.04%) 
Pain in extremity   2/49 (4.08%) 
Generalized muscle weakness   5/49 (10.20%) 
Muscle weakness lower limb   2/49 (4.08%) 
Muscle weakness trunk   1/49 (2.04%) 
Muscle weakness upper limb   1/49 (2.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other,   1/49 (2.04%) 
Nervous system disorders   
Cognitive disturbance   1/49 (2.04%) 
Dizziness   11/49 (22.45%) 
Dysgeusia   5/49 (10.20%) 
Headache   12/49 (24.49%) 
Hypersomnia   1/49 (2.04%) 
Lethargy   1/49 (2.04%) 
Movements involuntary   1/49 (2.04%) 
Nervous system disorders - Other, specify   7/49 (14.29%) 
Peripheral motor neuropathy   2/49 (4.08%) 
Peripheral sensory neuropathy   3/49 (6.12%) 
Syncope   1/49 (2.04%) 
Psychiatric disorders   
Anxiety   4/49 (8.16%) 
Confusion   1/49 (2.04%) 
Depression   2/49 (4.08%) 
Insomnia   7/49 (14.29%) 
Renal and urinary disorders   
Hematuria   1/49 (2.04%) 
Renal and urinary disorders - Other, specify   4/49 (8.16%) 
Urinary frequency   6/49 (12.24%) 
Urinary incontinence   1/49 (2.04%) 
Urinary tract pain   1/49 (2.04%) 
Acute kidney injury   1/49 (2.04%) 
Reproductive system and breast disorders   
Pelvic pain   1/49 (2.04%) 
Reproductive system and breast disorders - Other   1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Cough   9/49 (18.37%) 
Dyspnea   12/49 (24.49%) 
Hiccups   1/49 (2.04%) 
Hoarseness   2/49 (4.08%) 
Hypoxia   1/49 (2.04%) 
Nasal congestion   3/49 (6.12%) 
Postnasal drip   2/49 (4.08%) 
Productive cough   2/49 (4.08%) 
Pulmonary fibrosis   1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders - Other   5/49 (10.20%) 
Sore throat   5/49 (10.20%) 
Sinus disorder   1/49 (2.04%) 
Skin and subcutaneous tissue disorders   
Alopecia   5/49 (10.20%) 
Dry skin   7/49 (14.29%) 
Erythroderma   2/49 (4.08%) 
Hyperhidrosis   1/49 (2.04%) 
Pruritus   5/49 (10.20%) 
Rash acneiform   14/49 (28.57%) 
Rash maculo-papular   7/49 (14.29%) 
Skin and subcutaneous tissue disorders - Other, specify   16/49 (32.65%) 
Urticaria   1/49 (2.04%) 
Vascular disorders   
Hot flashes   1/49 (2.04%) 
Hypertension   4/49 (8.16%) 
Hypotension   3/49 (6.12%) 
Thromboembolic event   2/49 (4.08%) 
Indicates events were collected by systematic assessment
Because of the lack of clinical response, it was decided that enrollment should discontinue. Twenty patients who received MEK162 were evaluated for the primary outcome; secondary outcome was not evaluated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manuel Avedissian, M.D.
Organization: Yale University
Phone: 203-737-3669
EMail: manuel.avedissian@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02094872    
Other Study ID Numbers: 1408014446
NCI-2014-00670 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
WIRB Pro #20140190 ( Other Identifier: Western Institutional Review Board (WIRB) )
WO #1-822810-1 ( Other Identifier: Western Institutional Review Board (WIRB) )
Invest #161467 ( Other Identifier: Western Institutional Review Board (WIRB) )
Study #1144561 ( Other Identifier: Western Institutional Review Board (WIRB) )
2013-184 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
P30CA022453 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2014
First Posted: March 24, 2014
Results First Submitted: October 29, 2019
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020