Trial Outcomes & Findings for Selumetinib in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (NCT NCT01278615)
NCT ID: NCT01278615
Last Updated: 2016-02-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2016-02-03
Participant Flow
Participant milestones
| Measure |
Treatment (Selumetinib)
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 Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Selumetinib)
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 Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Selumetinib in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Selumetinib)
n=16 Participants
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
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsEstimates 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.
Outcome measures
| Measure |
Treatment (Selumetinib)
n=14 Participants
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
|
|---|---|
|
Response Rate (Complete Response [CR] and Partial Response [PR]) in Patients Treated With Selumetinib
|
0 percentage of response
Interval 0.0 to 23.0
|
PRIMARY outcome
Timeframe: Up to 3 yearsEstimates 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.
Outcome measures
| Measure |
Treatment (Selumetinib)
n=14 Participants
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
|
|---|---|
|
Disease Control Rate (Complete Response [CR], Partial Response [PR], and Stable Disease [SD]) in Patients Treated With Selumetinib
|
14.3 percentage of disease control
Interval 1.8 to 42.8
|
SECONDARY outcome
Timeframe: From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 yearsPopulation: Zero participants were analyzed due to no response.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPercentage 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.)
Outcome measures
| Measure |
Treatment (Selumetinib)
n=16 Participants
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
|
|---|---|
|
Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
37.5 percentage of participants
Interval 15.2 to 64.6
|
SECONDARY outcome
Timeframe: Date of study entry to the date of death, assessed up to 3 yearsThe 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.
Outcome measures
| Measure |
Treatment (Selumetinib)
n=14 Participants
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 Survival
|
129 days
Interval 58.0 to 134.0
|
SECONDARY outcome
Timeframe: Time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 yearsThe 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.
Outcome measures
| Measure |
Treatment (Selumetinib)
n=14 Participants
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
|
|---|---|
|
Progression-free Survival
|
34 days
Interval 14.0 to 73.0
|
SECONDARY outcome
Timeframe: 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.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.
Outcome measures
| Measure |
Treatment (Selumetinib)
n=14 Participants
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
|
|---|---|
|
Time to Treatment Failure
|
34 days
Interval 14.0 to 73.0
|
Adverse Events
Treatment (Selumetinib)
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Selumetinib)
n=16 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16
|
|
Cardiac disorders
Atrioventricular block complete
|
6.2%
1/16
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
6.2%
1/16
|
|
Gastrointestinal disorders
Colonic obstruction
|
6.2%
1/16
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
6.2%
1/16
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.2%
1/16
|
|
General disorders
Death NOS
|
6.2%
1/16
|
|
General disorders
Hypothermia
|
6.2%
1/16
|
|
General disorders
Pain
|
6.2%
1/16
|
|
Infections and infestations
Skin infection
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16
|
|
Injury, poisoning and procedural complications
Injury to kidney
|
12.5%
2/16
|
|
Investigations
Lymphocyte count decreased
|
6.2%
1/16
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16
|
|
Investigations
White blood cell decreased
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
1/16
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
1/16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.2%
1/16
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16
|
|
Vascular disorders
Hypotension
|
6.2%
1/16
|
|
Vascular disorders
Thromboembolic event
|
12.5%
2/16
|
Other adverse events
| Measure |
Treatment (Selumetinib)
n=16 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
43.8%
7/16
|
|
Eye disorders
Blurred vision
|
6.2%
1/16
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16
|
|
Gastrointestinal disorders
Diarrhea
|
31.2%
5/16
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
|
General disorders
Edema face
|
12.5%
2/16
|
|
General disorders
Edema limbs
|
18.8%
3/16
|
|
General disorders
Fatigue
|
43.8%
7/16
|
|
General disorders
Fever
|
12.5%
2/16
|
|
General disorders
Hypothermia
|
6.2%
1/16
|
|
Infections and infestations
Catheter related infection
|
6.2%
1/16
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16
|
|
Investigations
Aspartate aminotransferase increased
|
43.8%
7/16
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16
|
|
Investigations
Creatinine increased
|
25.0%
4/16
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
6.2%
1/16
|
|
Investigations
Lymphocyte count decreased
|
18.8%
3/16
|
|
Investigations
Neutrophil count decreased
|
12.5%
2/16
|
|
Investigations
Platelet count decreased
|
25.0%
4/16
|
|
Investigations
Weight gain
|
6.2%
1/16
|
|
Investigations
White blood cell decreased
|
18.8%
3/16
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
4/16
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
2/16
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
6/16
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
4/16
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
4/16
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.8%
3/16
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders Anorexia
|
25.0%
4/16
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
6.2%
1/16
|
|
Nervous system disorders
Oral dysesthesia
|
6.2%
1/16
|
|
Nervous system disorders
Paresthesia
|
6.2%
1/16
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16
|
|
Nervous system disorders
Tremor
|
6.2%
1/16
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
3/16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.8%
3/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.2%
1/16
|
|
Vascular disorders
Hypotension
|
6.2%
1/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60