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Trial record 53 of 881 for:    "Reticulum Cell Sarcoma"

Selumetinib in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01278615
Recruitment Status : Terminated (Closed Prematurely.)
First Posted : January 19, 2011
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
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
Condition Recurrent Adult Diffuse Large Cell Lymphoma
Interventions Other: Laboratory Biomarker Analysis
Drug: Selumetinib
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Selumetinib)
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Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Period Title: Overall Study
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Treatment (Selumetinib)
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Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
70
(28.7 to 86.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
7
  43.8%
Male
9
  56.3%
1.Primary Outcome
Title Response Rate (Complete Response [CR] and Partial Response [PR]) in Patients Treated With Selumetinib
Hide Description Estimates of the response rate based on best response (CR and PR) with the exact two-sided 95% confidence intervals. Response for this lymphoma clinical study was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Selumetinib)
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Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Participants Analyzed 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of response
0
(0 to 23)
2.Primary Outcome
Title Disease Control Rate (Complete Response [CR], Partial Response [PR], and Stable Disease [SD]) in Patients Treated With Selumetinib
Hide Description Estimates of the disease control rate with the exact two-sided 95% confidence intervals. Response was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586. Using these criteria, ‘disease control rate’ encompassed patients who had either a CR, PR, and SD.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Selumetinib)
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Participants Analyzed 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of disease control
14.3
(1.8 to 42.8)
3.Secondary Outcome
Title Duration of Response
Hide Description The Kaplan-Meier procedure will be used to characterize the duration of response. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.
Time Frame From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 years
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Hide Analysis Population Description
Zero participants were analyzed due to no response.
Arm/Group Title Treatment (Selumetinib)
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Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hide Description Percentage of patients experiencing any grade 3 or higher adverse event at least possibly attributed to the study drug. (Additional adverse event reporting will appear in the AE outcomes module.)
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Selumetinib)
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.5
(15.2 to 64.6)
5.Secondary Outcome
Title Overall Survival
Hide Description The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-death and the corresponding two-sided 95% confidence intervals will be provided.
Time Frame Date of study entry to the date of death, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Selumetinib)
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: days
129
(58 to 134)
6.Secondary Outcome
Title Progression-free Survival
Hide Description The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.
Time Frame Time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Selumetinib)
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: days
34
(14 to 73)
7.Secondary Outcome
Title Time to Treatment Failure
Hide Description The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.
Time Frame Time from study entry to treatment failure, defined as lymphoma progression or withdrawal from treatment due to adverse events, assessed up to 3 years. Patients who die without progression while still on therapy will be censored as of the time of death.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Selumetinib)
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

Overall Number of Participants Analyzed 14
Mean (95% Confidence Interval)
Unit of Measure: days
34
(14 to 73)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Selumetinib)
Hide Arm/Group Description

Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity

Laboratory Biomarker Analysis: Correlative studies

Selumetinib: Given PO

All-Cause Mortality
Treatment (Selumetinib)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Selumetinib)
Affected / at Risk (%)
Total   7/16 (43.75%) 
Blood and lymphatic system disorders   
Anemia  1/16 (6.25%) 
Cardiac disorders   
Atrioventricular block complete  1/16 (6.25%) 
Left ventricular systolic dysfunction  1/16 (6.25%) 
Gastrointestinal disorders   
Colonic obstruction  1/16 (6.25%) 
Gastrointestinal disorders - Other, specify  1/16 (6.25%) 
Pancreatic necrosis  1/16 (6.25%) 
Small intestinal obstruction  1/16 (6.25%) 
General disorders   
Death NOS  1/16 (6.25%) 
Hypothermia  1/16 (6.25%) 
Pain  1/16 (6.25%) 
Infections and infestations   
Skin infection  1/16 (6.25%) 
Injury, poisoning and procedural complications   
Fall  1/16 (6.25%) 
Injury to kidney  2/16 (12.50%) 
Investigations   
Lymphocyte count decreased  1/16 (6.25%) 
Neutrophil count decreased  2/16 (12.50%) 
White blood cell decreased  1/16 (6.25%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1/16 (6.25%) 
Muscle weakness lower limb  1/16 (6.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1/16 (6.25%) 
Psychiatric disorders   
Confusion  1/16 (6.25%) 
Renal and urinary disorders   
Urinary retention  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  2/16 (12.50%) 
Hypoxia  1/16 (6.25%) 
Respiratory failure  1/16 (6.25%) 
Vascular disorders   
Hypotension  1/16 (6.25%) 
Thromboembolic event  2/16 (12.50%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Selumetinib)
Affected / at Risk (%)
Total   11/16 (68.75%) 
Blood and lymphatic system disorders   
Anemia  7/16 (43.75%) 
Eye disorders   
Blurred vision  1/16 (6.25%) 
Gastrointestinal disorders   
Constipation  1/16 (6.25%) 
Diarrhea  5/16 (31.25%) 
Dry mouth  1/16 (6.25%) 
Dyspepsia  1/16 (6.25%) 
Dysphagia  1/16 (6.25%) 
Gastrointestinal disorders - Other, specify  1/16 (6.25%) 
Nausea  2/16 (12.50%) 
Vomiting  1/16 (6.25%) 
General disorders   
Edema face  2/16 (12.50%) 
Edema limbs  3/16 (18.75%) 
Fatigue  7/16 (43.75%) 
Fever  2/16 (12.50%) 
Hypothermia  1/16 (6.25%) 
Infections and infestations   
Catheter related infection  1/16 (6.25%) 
Investigations   
Alanine aminotransferase increased  3/16 (18.75%) 
Alkaline phosphatase increased  1/16 (6.25%) 
Aspartate aminotransferase increased  7/16 (43.75%) 
Blood bilirubin increased  1/16 (6.25%) 
Creatinine increased  4/16 (25.00%) 
Electrocardiogram QT corrected interval prolonged  1/16 (6.25%) 
Lymphocyte count decreased  3/16 (18.75%) 
Neutrophil count decreased  2/16 (12.50%) 
Platelet count decreased  4/16 (25.00%) 
Weight gain  1/16 (6.25%) 
White blood cell decreased  3/16 (18.75%) 
Metabolism and nutrition disorders   
Anorexia  4/16 (25.00%) 
Hypercalcemia  2/16 (12.50%) 
Hyperglycemia  6/16 (37.50%) 
Hypernatremia  1/16 (6.25%) 
Hypoalbuminemia  4/16 (25.00%) 
Hypocalcemia  4/16 (25.00%) 
Hypokalemia  1/16 (6.25%) 
Hypomagnesemia  3/16 (18.75%) 
Metabolism and nutrition disorders Anorexia  4/16 (25.00%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1/16 (6.25%) 
Nervous system disorders   
Headache  1/16 (6.25%) 
Oral dysesthesia  1/16 (6.25%) 
Paresthesia  1/16 (6.25%) 
Peripheral sensory neuropathy  1/16 (6.25%) 
Tremor  1/16 (6.25%) 
Psychiatric disorders   
Confusion  1/16 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1/16 (6.25%) 
Dyspnea  3/16 (18.75%) 
Skin and subcutaneous tissue disorders   
Dry skin  3/16 (18.75%) 
Pruritus  1/16 (6.25%) 
Rash acneiform  1/16 (6.25%) 
Skin and subcutaneous tissue disorders - Other, specify  1/16 (6.25%) 
Vascular disorders   
Hypotension  1/16 (6.25%) 
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: Dr. Sonali M. Smith
Organization: University of Chicago
Phone: 773-834-2895
EMail: smsmith@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01278615     History of Changes
Other Study ID Numbers: NCI-2011-02558
NCI-2011-02558 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NU-10H03
CDR0000690641
12-0110 ( Other Identifier: University of Chicago Comprehensive Cancer Center )
8611 ( Other Identifier: CTEP )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Submitted: January 15, 2011
First Posted: January 19, 2011
Results First Submitted: September 4, 2015
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016