Trial Outcomes & Findings for Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma (NCT NCT00392496)
NCT ID: NCT00392496
Last Updated: 2014-05-15
Results Overview
It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin's lymphoma and reviewed independently
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2014-05-15
Participant Flow
This trial was centrally activated on November 8, 2006 and closed to accrual on March 24, 2009. Patients were recruited from 5 cancer centres in Canada
Participant milestones
| Measure |
Arm I
This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Arm I
n=17 Participants
This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: patients evaluable for response
It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin's lymphoma and reviewed independently
Outcome measures
| Measure |
Arm I
n=15 Participants
This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Tumor Response
|
0 participants
|
Adverse Events
Arm I
Serious events: 13 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=17 participants at risk
This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Nervous system disorders
Grade 2 somnolence
|
5.9%
1/17
|
|
Investigations
Grade 2 Hypothyroidism
|
5.9%
1/17
|
|
Cardiac disorders
Grade 2 Left Ventricular Systolic Dysfunction
|
5.9%
1/17
|
|
General disorders
Grade 4 fatigue
|
5.9%
1/17
|
|
Investigations
Grade 3 ALT, gr 2 AST and gr 2 alkaline phosphatase
|
5.9%
1/17
|
|
Investigations
Hospitalization for gr 4 platelets and gr 3 hemoglobin
|
5.9%
1/17
|
|
Investigations
Grade 3 AST
|
5.9%
1/17
|
|
General disorders
Death not associated with CTCAE term
|
17.6%
3/17
|
|
Gastrointestinal disorders
Grade 2 dysphagia and hypothyroidism
|
5.9%
1/17
|
|
General disorders
Grade 2 Rigors/chills
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Grade 3 dyspnea
|
5.9%
1/17
|
|
Gastrointestinal disorders
Hospitalization for grade 3 GI Bleed
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Hospitalization for infected lymphoma lesion (skin: cellulitis grade 5)
|
5.9%
1/17
|
Other adverse events
| Measure |
Arm I
n=17 participants at risk
This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Supraventricular arrhythmia Sinus tachycardia
|
5.9%
1/17
|
|
Cardiac disorders
Hypertension
|
23.5%
4/17
|
|
Cardiac disorders
Hypotension
|
5.9%
1/17
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.9%
1/17
|
|
Cardiac disorders
Pericardial effusion
|
5.9%
1/17
|
|
General disorders
Fatigue
|
82.4%
14/17
|
|
General disorders
Fever
|
23.5%
4/17
|
|
General disorders
Insomnia
|
17.6%
3/17
|
|
General disorders
Rigors/chills
|
11.8%
2/17
|
|
General disorders
Sweating
|
11.8%
2/17
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Hand-foot
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17
|
|
Endocrine disorders
Hypothyroidism
|
11.8%
2/17
|
|
Gastrointestinal disorders
Anorexia
|
64.7%
11/17
|
|
Gastrointestinal disorders
Constipation
|
52.9%
9/17
|
|
Gastrointestinal disorders
Dehydration
|
17.6%
3/17
|
|
Gastrointestinal disorders
Diarrhea
|
47.1%
8/17
|
|
Gastrointestinal disorders
Distension
|
5.9%
1/17
|
|
Gastrointestinal disorders
Dry mouth
|
17.6%
3/17
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
2/17
|
|
Gastrointestinal disorders
Heartburn
|
47.1%
8/17
|
|
Gastrointestinal disorders
Mucositis (clinical exam) Oral cavity
|
23.5%
4/17
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Oral cavity
|
23.5%
4/17
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Pharynx
|
5.9%
1/17
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17
|
|
Gastrointestinal disorders
Taste alteration
|
23.5%
4/17
|
|
Gastrointestinal disorders
Vomiting
|
41.2%
7/17
|
|
Gastrointestinal disorders
GI - Other
|
11.8%
2/17
|
|
Blood and lymphatic system disorders
Hemorrhage pulmonary Nose
|
17.6%
3/17
|
|
Blood and lymphatic system disorders
Hemorrhage, GI Oral cavity
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Hemorrhage, GI Stomach
|
5.9%
1/17
|
|
Infections and infestations
Infection with normal ANC Bladder
|
5.9%
1/17
|
|
Infections and infestations
Infection with normal ANC Lung
|
5.9%
1/17
|
|
Infections and infestations
Infection with normal ANC Pelvis NOS
|
5.9%
1/17
|
|
Infections and infestations
Infection with normal ANC Skin
|
5.9%
1/17
|
|
Infections and infestations
Infection with normal ANC Upper airway NOS
|
5.9%
1/17
|
|
Infections and infestations
Infection with unknown ANC Blood
|
5.9%
1/17
|
|
Infections and infestations
Infection with unknown ANC Lip/perioral
|
5.9%
1/17
|
|
Infections and infestations
Infection - Other
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Edema: limb
|
23.5%
4/17
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
11.8%
2/17
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Gait/walking
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Whole body/generalized
|
5.9%
1/17
|
|
Nervous system disorders
Confusion
|
5.9%
1/17
|
|
Nervous system disorders
Mood alteration Anxiety
|
5.9%
1/17
|
|
Nervous system disorders
Mood alteration Depression
|
5.9%
1/17
|
|
Nervous system disorders
Neuropathy-sensory
|
41.2%
7/17
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17
|
|
Eye disorders
Diplopia
|
5.9%
1/17
|
|
General disorders
Pain Abdomen NOS
|
35.3%
6/17
|
|
General disorders
Pain Back
|
29.4%
5/17
|
|
General disorders
Pain Bladder
|
5.9%
1/17
|
|
General disorders
Pain Bone
|
5.9%
1/17
|
|
General disorders
Pain Chest/thorax NOS
|
5.9%
1/17
|
|
General disorders
Pain Extremity-limb
|
17.6%
3/17
|
|
General disorders
Pain Head/headache
|
17.6%
3/17
|
|
General disorders
Pain Joint
|
17.6%
3/17
|
|
General disorders
Pain Lymph node
|
5.9%
1/17
|
|
General disorders
Pain Middle ear
|
5.9%
1/17
|
|
General disorders
Pain Muscle
|
11.8%
2/17
|
|
General disorders
Pain Oral cavity
|
23.5%
4/17
|
|
General disorders
Pain Pain NOS
|
5.9%
1/17
|
|
General disorders
Pain Tumor pain
|
11.8%
2/17
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.9%
1/17
|
|
General disorders
Cough
|
35.3%
6/17
|
|
General disorders
Dyspnea
|
47.1%
8/17
|
|
General disorders
Pleural effusion
|
11.8%
2/17
|
|
General disorders
Voice changes
|
11.8%
2/17
|
|
General disorders
Pulmonary - Other
|
5.9%
1/17
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
1/17
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.9%
1/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60