Trial Outcomes & Findings for Pazopanib in Treating Patients With Malignant Pleural Mesothelioma (NCT NCT00459862)
NCT ID: NCT00459862
Last Updated: 2015-02-24
Results Overview
The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
6 months
Results posted on
2015-02-24
Participant Flow
Thirty-four participants were accrued between May 2007 and October 2008.
All 34 participants were evaluable for the primary endpoint.
Participant milestones
| Measure |
Arm I
Patients receive 800mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pazopanib in Treating Patients With Malignant Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Arm I
n=34 Participants
Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All 34 participants were analyzed for this endpoint.
The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.
Outcome measures
| Measure |
Arm I
n=34 Participants
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)
|
47.8 percentage of participants
|
SECONDARY outcome
Timeframe: From study enrollment to time of death from any cause or censored at last follow-up, up to 3 yearsPopulation: All 34 participants were evaluable for this endpoint.
Outcome measures
| Measure |
Arm I
n=34 Participants
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
11.5 months
Interval 6.2 to 18.2
|
SECONDARY outcome
Timeframe: From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 yearsPopulation: All 34 participants were analyzed for this endpoint.
Outcome measures
| Measure |
Arm I
n=34 Participants
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival Assessed by RECIST
|
4.2 months
Interval 2.5 to 5.9
|
SECONDARY outcome
Timeframe: Participants will be evaluated every cycle during treatmentPopulation: All 34 participants were evaluable for adverse events.
The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.
Outcome measures
| Measure |
Arm I
n=34 Participants
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Determine the Clinical Toxicities of This Drug in This Participant Population.
Grade 3 or Higher
|
23 participants
|
|
Determine the Clinical Toxicities of This Drug in This Participant Population.
Grade 4 or Higher
|
5 participants
|
|
Determine the Clinical Toxicities of This Drug in This Participant Population.
Grade 5
|
3 participants
|
SECONDARY outcome
Timeframe: From study enrollment to the first date of disease progressionPopulation: All 34 participants were evaluable for this endpoint.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline LD.
Outcome measures
| Measure |
Arm I
n=34 Participants
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.
Partial Response (PR)
|
5 participants
|
|
Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.
Complete Response (CR)
|
0 participants
|
SECONDARY outcome
Timeframe: Participants will be evaluated every cycle during treatment, up to 2 yearsPopulation: All 34 participants were evaluable for this endpoint.
To evaluate the confirmed response rate of pazopanib in patients with MPM based on the RECIST criteria for MPM. Responses are confirmed by repeat assessments that are be performed no less than 4 weeks after the criteria for response are first met. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Arm I
n=34 Participants
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Response Rate
|
5.9 percentage of patients
Interval 0.7 to 19.7
|
Adverse Events
Arm I
Serious events: 13 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=34 participants at risk
Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Number of events 2
|
|
General disorders
Chest pain
|
2.9%
1/34 • Number of events 1
|
|
General disorders
Death
|
2.9%
1/34 • Number of events 1
|
|
General disorders
Disease progression
|
2.9%
1/34 • Number of events 1
|
|
General disorders
Fatigue
|
11.8%
4/34 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Creatinine increased
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
2.9%
1/34 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
2/34 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.9%
2/34 • Number of events 2
|
|
Nervous system disorders
Taste alteration
|
2.9%
1/34 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.8%
3/34 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.9%
1/34 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1
|
Other adverse events
| Measure |
Arm I
n=34 participants at risk
Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
50.0%
17/34 • Number of events 69
|
|
Cardiac disorders
Atrial tachycardia
|
2.9%
1/34 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
2.9%
1/34 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
1/34 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/34 • Number of events 6
|
|
Eye disorders
Vision blurred
|
2.9%
1/34 • Number of events 4
|
|
Eye disorders
Watering eyes
|
5.9%
2/34 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain
|
47.1%
16/34 • Number of events 42
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.8%
4/34 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
44.1%
15/34 • Number of events 55
|
|
Gastrointestinal disorders
Dry mouth
|
2.9%
1/34 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
8.8%
3/34 • Number of events 7
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Gastroscopy abnormal
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Gingival pain
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
5.9%
2/34 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
55.9%
19/34 • Number of events 65
|
|
Gastrointestinal disorders
Rectal pain
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
35.3%
12/34 • Number of events 23
|
|
General disorders
Edema limbs
|
2.9%
1/34 • Number of events 1
|
|
General disorders
Fatigue
|
79.4%
27/34 • Number of events 156
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
2.9%
1/34 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
55.9%
19/34 • Number of events 44
|
|
Investigations
Alkaline phosphatase increased
|
11.8%
4/34 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increased
|
55.9%
19/34 • Number of events 47
|
|
Investigations
Bilirubin increased
|
14.7%
5/34 • Number of events 18
|
|
Investigations
Leukocyte count decreased
|
32.4%
11/34 • Number of events 26
|
|
Investigations
Lymphocyte count decreased
|
5.9%
2/34 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
14.7%
5/34 • Number of events 6
|
|
Investigations
Platelet count decreased
|
29.4%
10/34 • Number of events 23
|
|
Investigations
Weight loss
|
8.8%
3/34 • Number of events 7
|
|
Metabolism and nutrition disorders
Anorexia
|
38.2%
13/34 • Number of events 30
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.8%
4/34 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.7%
5/34 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.8%
4/34 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.8%
3/34 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.9%
1/34 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.8%
3/34 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.9%
1/34 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
2/34 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.9%
1/34 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/34 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
11.8%
4/34 • Number of events 5
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
2.9%
1/34 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.6%
6/34 • Number of events 30
|
|
Nervous system disorders
Syncope
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
2.9%
1/34 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
29.4%
10/34 • Number of events 37
|
|
Psychiatric disorders
Anxiety
|
11.8%
4/34 • Number of events 10
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • Number of events 4
|
|
Psychiatric disorders
Depression
|
5.9%
2/34 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
5.9%
2/34 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
38.2%
13/34 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.7%
5/34 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.5%
9/34 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
2.9%
1/34 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
2.9%
1/34 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.8%
3/34 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
2.9%
1/34 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
35.3%
12/34 • Number of events 32
|
|
Vascular disorders
Hypertension
|
79.4%
27/34 • Number of events 70
|
|
Vascular disorders
Vascular disorder
|
2.9%
1/34 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60