Trial Outcomes & Findings for Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma (NCT NCT00392444)
NCT ID: NCT00392444
Last Updated: 2014-05-21
Results Overview
Number of patients who had objective responses after radiology review
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2014-05-21
Participant Flow
This study was centrally activated on November 10, 2006 and the study was closed to accrual on September 10, 2010. Patients were recruited from 9 cancer clinics in Canada
Participant milestones
| Measure |
Treatment (Sunitinib Malate)
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Treatment (Sunitinib Malate)
n=35 Participants
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
35 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: 1 cancelled patient and 4 ineligible patients were excluded from analysis.
Number of patients who had objective responses after radiology review
Outcome measures
| Measure |
Treatment (Sunitinib Malate)
n=35 Participants
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response (Partial and Complete) Per RECIST
|
1 participants
|
Adverse Events
Treatment (Sunitinib Malate)
Serious events: 21 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Sunitinib Malate)
n=35 participants at risk
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hospitalization for Grade 3 hemorrhage
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Grade 3 bronchopulmonary NOS
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Grade 3 dyspnea
|
8.6%
3/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Grade 3 cough
|
2.9%
1/35
|
|
General disorders
Hospitalization for Grade 3 fatigue
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 pulmonary emboli
|
2.9%
1/35
|
|
Blood and lymphatic system disorders
Hospitalized for grade 3 edema
|
2.9%
1/35
|
|
Infections and infestations
Grade 3 infection with normal ANC
|
2.9%
1/35
|
|
Investigations
Grade 3 hyperkalemia
|
2.9%
1/35
|
|
General disorders
Hospitalization for Grade 2 fatigue
|
2.9%
1/35
|
|
Gastrointestinal disorders
Grade 2 Esophagitis
|
2.9%
1/35
|
|
Endocrine disorders
Grade 2 Hypothyroidism
|
2.9%
1/35
|
|
Vascular disorders
Grade 3 thrombosis/thrombus/embolism
|
2.9%
1/35
|
|
Gastrointestinal disorders
Hospitalized for grade 3 diarrhea
|
5.7%
2/35
|
|
Infections and infestations
Grade 2 Infection with normal ANC
|
2.9%
1/35
|
|
Gastrointestinal disorders
Grade 2 flatulence
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for grade 2 cough
|
2.9%
1/35
|
|
Nervous system disorders
Grade 2 dizziness
|
2.9%
1/35
|
|
Vascular disorders
Grade 4 thrombocytopenia
|
2.9%
1/35
|
|
Cardiac disorders
Grade 2 left ventricular systolic dysfunction
|
2.9%
1/35
|
|
Ear and labyrinth disorders
Grade 2 tinnitus
|
2.9%
1/35
|
|
General disorders
Death not associated with CTCAE term
|
5.7%
2/35
|
|
General disorders
Hospitalization for grade 3 pain
|
2.9%
1/35
|
|
Nervous system disorders
Hospitalized for grade 2 seizure
|
2.9%
1/35
|
|
Infections and infestations
Grade 5 infection with unknown ANC
|
2.9%
1/35
|
|
Gastrointestinal disorders
Hospitalization for Grade 3 dehydration
|
2.9%
1/35
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization for grade 4 malignant pericardial effusion
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalized for grade 3 pulmonary/upper respiratory other - subcutaneous emphysema
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for grade 4 obstruction/stenosis of airway - Bronchus
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pleural effusion grade 3
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Grade 4 dyspnea
|
2.9%
1/35
|
|
Cardiac disorders
Grade 2 hypertension
|
2.9%
1/35
|
Other adverse events
| Measure |
Treatment (Sunitinib Malate)
n=35 participants at risk
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Immune system disorders
Rhinitis
|
5.7%
2/35
|
|
Cardiac disorders
Hypertension
|
28.6%
10/35
|
|
General disorders
Fatigue
|
97.1%
34/35
|
|
General disorders
Fever
|
11.4%
4/35
|
|
General disorders
Insomnia
|
31.4%
11/35
|
|
General disorders
Rigors/chills
|
11.4%
4/35
|
|
General disorders
Sweating
|
22.9%
8/35
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.6%
3/35
|
|
Skin and subcutaneous tissue disorders
Bruising
|
5.7%
2/35
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.1%
6/35
|
|
Skin and subcutaneous tissue disorders
Hand-foot
|
22.9%
8/35
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
8.6%
3/35
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35
|
|
Skin and subcutaneous tissue disorders
Rash
|
34.3%
12/35
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
20.0%
7/35
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
2/35
|
|
Gastrointestinal disorders
Anorexia
|
65.7%
23/35
|
|
Gastrointestinal disorders
Constipation
|
51.4%
18/35
|
|
Gastrointestinal disorders
Dehydration
|
5.7%
2/35
|
|
Gastrointestinal disorders
Diarrhea
|
51.4%
18/35
|
|
Gastrointestinal disorders
Distension
|
11.4%
4/35
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
5/35
|
|
Gastrointestinal disorders
Flatulence
|
11.4%
4/35
|
|
Gastrointestinal disorders
Heartburn
|
28.6%
10/35
|
|
Gastrointestinal disorders
Mucositis (clinical exam) Oral cavity
|
48.6%
17/35
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Oral cavity
|
11.4%
4/35
|
|
Gastrointestinal disorders
Nausea
|
68.6%
24/35
|
|
Gastrointestinal disorders
Taste alteration
|
54.3%
19/35
|
|
Gastrointestinal disorders
Vomiting
|
31.4%
11/35
|
|
Gastrointestinal disorders
GI - Other
|
5.7%
2/35
|
|
Blood and lymphatic system disorders
Hemorrhage pulmonary Bronchopulmonary NOS
|
11.4%
4/35
|
|
Blood and lymphatic system disorders
Hemorrhage pulmonary Nose
|
40.0%
14/35
|
|
Blood and lymphatic system disorders
Hemorrhage - Other
|
5.7%
2/35
|
|
Infections and infestations
Infection with normal ANC Bronchus
|
5.7%
2/35
|
|
Infections and infestations
Infection with normal ANC Lung
|
5.7%
2/35
|
|
Infections and infestations
Infection with normal ANC Skin
|
5.7%
2/35
|
|
Blood and lymphatic system disorders
Edema: limb
|
25.7%
9/35
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
11.4%
4/35
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Extremity-lowe
|
5.7%
2/35
|
|
Nervous system disorders
Cognitive disturbance
|
5.7%
2/35
|
|
Nervous system disorders
Confusion
|
5.7%
2/35
|
|
Nervous system disorders
Dizziness
|
28.6%
10/35
|
|
Nervous system disorders
Involuntary movement
|
8.6%
3/35
|
|
Nervous system disorders
Mood alteration Anxiety
|
14.3%
5/35
|
|
Nervous system disorders
Mood alteration Depression
|
5.7%
2/35
|
|
Nervous system disorders
Neuropathy-motor
|
5.7%
2/35
|
|
Nervous system disorders
Neuropathy-sensory
|
31.4%
11/35
|
|
Eye disorders
Ocular - Other
|
5.7%
2/35
|
|
General disorders
Pain Abdomen NOS
|
48.6%
17/35
|
|
General disorders
Pain Back
|
28.6%
10/35
|
|
General disorders
Pain Bone
|
5.7%
2/35
|
|
General disorders
Pain Chest/thorax NOS
|
54.3%
19/35
|
|
General disorders
Pain Extremity-limb
|
11.4%
4/35
|
|
General disorders
Pain Head/headache
|
28.6%
10/35
|
|
General disorders
Pain Joint
|
22.9%
8/35
|
|
General disorders
Pain Muscle
|
14.3%
5/35
|
|
General disorders
Pain Oral cavity
|
5.7%
2/35
|
|
General disorders
Pain Throat/pharynx/larynx
|
11.4%
4/35
|
|
General disorders
Pain Tumor pain
|
17.1%
6/35
|
|
General disorders
Pain - Other
|
5.7%
2/35
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
68.6%
24/35
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
88.6%
31/35
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.6%
3/35
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
5.7%
2/35
|
|
Renal and urinary disorders
Urinary frequency
|
5.7%
2/35
|
|
General disorders
Flu-like syndrome
|
8.6%
3/35
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.7%
2/35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60