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Trial record 18 of 50 for:    MK-2206

Study of Akt Inhibitor MK2206 in Patients With Relapsed Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01258998
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia
B-cell Chronic Lymphocytic Leukemia
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Drug: Akt inhibitor MK2206
Other: laboratory biomarker analysis
Enrollment 60
Recruitment Details Recruitment Period: December 10, 2010 to February 20, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Akt Inhibitor MK2206
Hide Arm/Group Description Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
Period Title: Overall Study
Started 60
Completed 59
Not Completed 1
Reason Not Completed
Ineligible             1
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
58
(21 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
21
  35.0%
Male
39
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate. Logistic regression utilized to assess the effect of patient demographic factors on OR.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on intent-to-treat analysis.
Arm/Group Title Akt Inhibitor MK2206
Hide Arm/Group Description:
Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: participants
14
2.Secondary Outcome
Title Progression-free Survival
Hide Description Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Time Frame From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Duration of Response
Hide Description Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Time Frame From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival
Hide Description Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Time Frame Up to 30 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in Cytokine Levels
Hide Description Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.
Time Frame Baseline to up to 30 days post-treatment
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in Chemokine Levels
Hide Description Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.
Time Frame Baseline to up to 30 days post-treatment
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change in Biomarker Levels of Interest (Akt, pAKT, and Apoptosis [Annexin-V])
Hide Description Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.
Time Frame Baseline to up to 30 days post-treatment
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Toxicity data will be summarized by frequency tables. The association between both type and severity of toxicity and the treatment groups will be evaluated.
Time Frame Up to 30 days
Outcome Measure Data Not Reported
Time Frame Adverse Events (AEs) were collected from the time of the first treatment to discontinuation of participant in study. Collection period: January 2011 to January 2014 study not yet terminated.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Akt Inhibitor MK2206)
Hide Arm/Group Description Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
All-Cause Mortality
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%) # Events
Total   5/60 (8.33%)    
Blood and lymphatic system disorders   
Blood and lymphatic system disorders  1  1/60 (1.67%)  1
Neutrophil count decreased  1  1/60 (1.67%)  1
Lymphocyte count decreased  1  3/60 (5.00%)  3
Anemia  1  1/60 (1.67%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/60 (1.67%)  1
Hypercalcemia  1  1/60 (1.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Akt Inhibitor MK2206)
Affected / at Risk (%) # Events
Total   59/60 (98.33%)    
Blood and lymphatic system disorders   
Alanine aminotransferase increased  1  1/60 (1.67%)  8
Alkaline phosphatase increased  1  1/60 (1.67%)  29
Anemia  1  11/60 (18.33%)  71
Aspartate aminotransferase increased  1  3/60 (5.00%)  12
Blood bilirubin increased  1  1/60 (1.67%)  6
Creatinine increased  1  1/60 (1.67%)  14
Edema limbs  1  1/60 (1.67%)  10
Edema trunk  1  1/60 (1.67%)  1
Hypercalcemia  1  1/60 (1.67%)  8
Hyperglycemia  1  5/60 (8.33%)  89
Hyperkalemia  1  2/60 (3.33%)  14
Hypernatremia  1  1/60 (1.67%)  4
Hypertriglyceridemia  1  1/60 (1.67%)  1
Hyperuricemia  1  1/60 (1.67%)  4
Hypoalbuminemia  1  3/60 (5.00%)  16
Hypocalcemia  1  1/60 (1.67%)  9
Hypoglycemia  1  2/60 (3.33%)  4
Hypokalemia  1  1/60 (1.67%)  6
Hypomagnesemia  1  1/60 (1.67%)  16
Hyponatremia  1  1/60 (1.67%)  5
Hypophosphatemia  1  1/60 (1.67%)  16
Leukocytosis  1  3/60 (5.00%)  13
Lymphedema  1  1/60 (1.67%)  2
Lymphocyte count decreased  1  1/60 (1.67%)  59
Neutrophil count decreased  1  3/60 (5.00%)  19
Platelet count decreased  1  3/60 (5.00%)  47
White blood cell decreased  1  3/60 (5.00%)  29
Cardiac disorders   
Atrial fibrillation  1  1/60 (1.67%)  2
Chest pain - cardiac  1  1/60 (1.67%)  3
Hypertension  1  4/60 (6.67%)  8
Hypotension  1  1/60 (1.67%)  2
Left ventricular systolic dysfunction  1  1/60 (1.67%)  1
Non-cardiac chest pain  1  1/60 (1.67%)  1
Ear and labyrinth disorders   
Ear pain  1  1/60 (1.67%)  1
Tinnitus  1  1/60 (1.67%)  5
Endocrine disorders   
Hyperthyroidism  1  1/60 (1.67%)  1
Hypothyroidism  1  1/60 (1.67%)  5
Eye disorders   
Blurred vision  1  1/60 (1.67%)  4
Conjunctivitis  1  1/60 (1.67%)  5
Dry eye  1  1/60 (1.67%)  2
Eye pain  1  1/60 (1.67%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/60 (1.67%)  4
Anorexia  1  1/60 (1.67%)  9
Colonic hemorrhage  1  1/60 (1.67%)  1
Constipation  1  1/60 (1.67%)  8
Dehydration  1  1/60 (1.67%)  2
Diarrhea  1  2/60 (3.33%)  12
Dry mouth  1  1/60 (1.67%)  1
Dyspepsia  1  1/60 (1.67%)  1
Dysphagia  1  2/60 (3.33%)  3
Gastroesophageal reflux disease  1  1/60 (1.67%)  1
Gastrointestinal disorders  1  3/60 (5.00%)  4
Mucositis oral  1  1/60 (1.67%)  1
Nausea  1  1/60 (1.67%)  15
Rectal hemorrhage  1  1/60 (1.67%)  1
Rectal pain  1  1/60 (1.67%)  1
Vomiting  1  1/60 (1.67%)  3
General disorders   
Chills  1  1/60 (1.67%)  2
Fatigue  1  4/60 (6.67%)  24
Fever  1  1/60 (1.67%)  14
General disorders and administration site conditions  1  2/60 (3.33%)  4
Insomnia  1  1/60 (1.67%)  6
Lethargy  1  1/60 (1.67%)  2
Malaise  1  1/60 (1.67%)  3
Pain  1  2/60 (3.33%)  8
Weight loss  1  1/60 (1.67%)  1
Hepatobiliary disorders   
Hepatobiliary disorders  1  1/60 (1.67%)  1
Pancreatitis  1  1/60 (1.67%)  1
Immune system disorders   
Allergic rhinitis  1  2/60 (3.33%)  14
Infections and infestations   
Infections and infestations  1  1/60 (1.67%)  4
Investigations   
Investigations  1  1/60 (1.67%)  2
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/60 (1.67%)  3
Back pain  1  2/60 (3.33%)  2
Bone pain  1  2/60 (3.33%)  2
Flank pain  1  1/60 (1.67%)  1
Fracture  1  1/60 (1.67%)  1
Gait disturbance  1  1/60 (1.67%)  2
Musculoskeletal and connective tissue disorder  1  1/60 (1.67%)  2
Neck pain  1  1/60 (1.67%)  2
Pain in extremity  1  1/60 (1.67%)  1
Wrist fracture  1  1/60 (1.67%)  1
Nervous system disorders   
Anxiety  1  2/60 (3.33%)  10
Confusion  1  1/60 (1.67%)  2
Depression  1  3/60 (5.00%)  8
Dizziness  1  1/60 (1.67%)  5
Facial nerve disorder  1  1/60 (1.67%)  1
Facial pain  1  1/60 (1.67%)  1
Headache  1  1/60 (1.67%)  10
Memory impairment  1  1/60 (1.67%)  1
Paresthesia  1  3/60 (5.00%)  5
Peripheral motor neuropathy  1  1/60 (1.67%)  1
Peripheral sensory neuropathy  1  1/60 (1.67%)  15
Seizure  1  1/60 (1.67%)  1
Tremor  1  1/60 (1.67%)  1
Psychiatric disorders   
Psychiatric disorders  1  1/60 (1.67%)  1
Renal and urinary disorders   
Renal and urinary disorders  1  1/60 (1.67%)  5
Urinary frequency  1  1/60 (1.67%)  2
Urinary retention  1  1/60 (1.67%)  1
Urinary tract infection  1  1/60 (1.67%)  1
Urinary tract pain  1  1/60 (1.67%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  2/60 (3.33%)  2
Pelvic pain  1  1/60 (1.67%)  1
Vaginal discharge  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Chest wall pain  1  1/60 (1.67%)  4
Cough  1  1/60 (1.67%)  22
Dysarthria  1  1/60 (1.67%)  1
Dyspnea  1  1/60 (1.67%)  12
Epistaxis  1  1/60 (1.67%)  1
Mucosal infection  1  1/60 (1.67%)  1
Nasal congestion  1  1/60 (1.67%)  5
Pharyngitis  1  1/60 (1.67%)  1
Pharyngolaryngeal pain  1  1/60 (1.67%)  1
Pleural effusion  1  1/60 (1.67%)  1
Pneumonitis  1  1/60 (1.67%)  2
Postnasal drip  1  1/60 (1.67%)  1
Productive cough  1  1/60 (1.67%)  3
Sinus bradycardia  1  1/60 (1.67%)  1
Sinus tachycardia  1  1/60 (1.67%)  2
Sinusitis  1  1/60 (1.67%)  1
Sore throat  1  1/60 (1.67%)  4
Upper respiratory infection  1  2/60 (3.33%)  11
Wheezing  1  1/60 (1.67%)  1
Skin and subcutaneous tissue disorders   
Bruising  1  1/60 (1.67%)  1
Bullous dermatitis  1  1/60 (1.67%)  1
Dry skin  1  1/60 (1.67%)  7
Flushing  1  1/60 (1.67%)  1
Pruritus  1  1/60 (1.67%)  16
Rash acneiform  1  1/60 (1.67%)  1
Rash maculo-papular  1  2/60 (3.33%)  59
Skin and subcutaneous tissue disorders  1  1/60 (1.67%)  4
Skin hypopigmentation  1  1/60 (1.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Yasuhiro Oki, Assistant Professor, Lymphoma/Myeloma
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01258998     History of Changes
Other Study ID Numbers: NCI-2012-02890
NCI-2012-02890 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-2011-00275
2010‐0261 ( Other Identifier: M D Anderson Cancer Center )
8728 ( Other Identifier: CTEP )
N01CM00039 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2010
First Posted: December 13, 2010
Results First Submitted: October 9, 2015
Results First Posted: November 10, 2015
Last Update Posted: November 10, 2015