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Pazopanib in Treating Patients With Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00459862
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : December 5, 2013
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Malignant Mesothelioma
Localized Malignant Mesothelioma
Recurrent Malignant Mesothelioma
Interventions Other: laboratory biomarker analysis
Drug: pazopanib hydrochloride
Enrollment 34
Recruitment Details Thirty-four participants were accrued between May 2007 and October 2008.
Pre-assignment Details All 34 participants were evaluable for the primary endpoint.
Arm/Group Title Arm I
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 34
Completed 34
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
73
(49 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
6
  17.6%
Male
28
  82.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 34 participants were analyzed for this endpoint.
Arm/Group Title Arm I
Hide Arm/Group Description:
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 Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of participants
47.8
2.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 34 participants were evaluable for this endpoint.
Arm/Group Title Arm I
Hide Arm/Group Description:
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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
11.5
(6.2 to 18.2)
3.Secondary Outcome
Title Progression-free Survival Assessed by RECIST
Hide Description [Not Specified]
Time Frame From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 34 participants were analyzed for this endpoint.
Arm/Group Title Arm I
Hide Arm/Group Description:
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 Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
4.2
(2.5 to 5.9)
4.Secondary Outcome
Title Determine the Clinical Toxicities of This Drug in This Participant Population.
Hide Description The number of participants with a reported Grade 3, Grade 4, and Grade 5 toxicity, regardless of attribution, will be tabulated.
Time Frame Participants will be evaluated every cycle during treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All 34 participants were evaluable for adverse events.
Arm/Group Title Arm I
Hide Arm/Group Description:
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 Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: participants
Grade 3 or Higher 23
Grade 4 or Higher 5
Grade 5 3
5.Secondary Outcome
Title Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.
Hide Description

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.
Time Frame From study enrollment to the first date of disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
All 34 participants were evaluable for this endpoint.
Arm/Group Title Arm I
Hide Arm/Group Description:
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 Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: participants
Partial Response (PR) 5
Complete Response (CR) 0
6.Secondary Outcome
Title Overall Response Rate
Hide Description

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.
Time Frame Participants will be evaluated every cycle during treatment, up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 34 participants were evaluable for this endpoint.
Arm/Group Title Arm I
Hide Arm/Group Description:
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 Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
5.9
(0.7 to 19.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description 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.
All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   13/34 (38.24%)    
Blood and lymphatic system disorders   
Hemoglobin decreased † 1  1/34 (2.94%)  1
Gastrointestinal disorders   
Dyspepsia † 1  1/34 (2.94%)  1
Flatulence † 1  1/34 (2.94%)  1
Nausea † 1  2/34 (5.88%)  2
Vomiting † 1  2/34 (5.88%)  2
General disorders   
Chest pain † 1  1/34 (2.94%)  1
Death † 1  1/34 (2.94%)  1
Disease progression † 1  1/34 (2.94%)  1
Fatigue † 1  4/34 (11.76%)  4
Infections and infestations   
Pneumonia † 1  1/34 (2.94%)  1
Upper respiratory infection † 1  1/34 (2.94%)  1
Investigations   
Alanine aminotransferase increased † 1  1/34 (2.94%)  1
Alkaline phosphatase increased † 1  1/34 (2.94%)  1
Aspartate aminotransferase increased † 1  1/34 (2.94%)  1
Creatinine increased † 1  1/34 (2.94%)  1
Laboratory test abnormal † 1  1/34 (2.94%)  2
Leukocyte count decreased † 1  1/34 (2.94%)  1
Metabolism and nutrition disorders   
Anorexia † 1  1/34 (2.94%)  1
Dehydration † 1  1/34 (2.94%)  1
Hyperglycemia † 1  1/34 (2.94%)  1
Hypophosphatemia † 1  1/34 (2.94%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness † 1  2/34 (5.88%)  2
Nervous system disorders   
Dizziness † 1  1/34 (2.94%)  1
Peripheral sensory neuropathy † 1  1/34 (2.94%)  1
Syncope † 1  2/34 (5.88%)  2
Taste alteration † 1  1/34 (2.94%)  1
Psychiatric disorders   
Insomnia † 1  1/34 (2.94%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome † 1  1/34 (2.94%)  1
Dyspnea † 1  3/34 (8.82%)  3
Pleural effusion † 1  1/34 (2.94%)  1
Pleuritic pain † 1  1/34 (2.94%)  1
Pneumonitis † 1  1/34 (2.94%)  1
Vascular disorders   
Hypertension † 1  1/34 (2.94%)  1
Hypotension † 1  1/34 (2.94%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I
Affected / at Risk (%) # Events
Total   34/34 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased † 1  17/34 (50.00%)  69
Cardiac disorders   
Atrial tachycardia † 1  1/34 (2.94%)  1
Sinus bradycardia † 1  1/34 (2.94%)  1
Sinus tachycardia † 1  1/34 (2.94%)  2
Ear and labyrinth disorders   
Tinnitus † 1  1/34 (2.94%)  6
Eye disorders   
Vision blurred † 1  1/34 (2.94%)  4
Watering eyes † 1  2/34 (5.88%)  7
Gastrointestinal disorders   
Abdominal pain † 1  16/34 (47.06%)  42
Anal hemorrhage † 1  1/34 (2.94%)  1
Constipation † 1  4/34 (11.76%)  6
Diarrhea † 1  15/34 (44.12%)  55
Dry mouth † 1  1/34 (2.94%)  2
Dyspepsia † 1  1/34 (2.94%)  1
Ear, nose and throat examination abnormal † 1  3/34 (8.82%)  7
Flatulence † 1  2/34 (5.88%)  3
Gastritis † 1  1/34 (2.94%)  1
Gastroscopy abnormal † 1  1/34 (2.94%)  1
Gingival pain † 1  1/34 (2.94%)  1
Intra-abdominal hemorrhage † 1  2/34 (5.88%)  2
Mucositis oral † 1  1/34 (2.94%)  1
Nausea † 1  19/34 (55.88%)  65
Rectal pain † 1  1/34 (2.94%)  1
Upper gastrointestinal hemorrhage † 1  1/34 (2.94%)  1
Vomiting † 1  12/34 (35.29%)  23
General disorders   
Edema limbs † 1  1/34 (2.94%)  1
Fatigue † 1  27/34 (79.41%)  156
Infections and infestations   
Pneumonia † 1  1/34 (2.94%)  1
Injury, poisoning and procedural complications   
Bruising † 1  1/34 (2.94%)  1
Investigations   
Alanine aminotransferase increased † 1  19/34 (55.88%)  44
Alkaline phosphatase increased † 1  4/34 (11.76%)  5
Aspartate aminotransferase increased † 1  19/34 (55.88%)  47
Bilirubin increased † 1  5/34 (14.71%)  18
Leukocyte count decreased † 1  11/34 (32.35%)  26
Lymphocyte count decreased † 1  2/34 (5.88%)  2
Neutrophil count decreased † 1  5/34 (14.71%)  6
Platelet count decreased † 1  10/34 (29.41%)  23
Weight loss † 1  3/34 (8.82%)  7
Metabolism and nutrition disorders   
Anorexia † 1  13/34 (38.24%)  30
Dehydration † 1  1/34 (2.94%)  1
Hyperglycemia † 1  4/34 (11.76%)  6
Hyperkalemia † 1  1/34 (2.94%)  1
Hypoalbuminemia † 1  5/34 (14.71%)  6
Hypocalcemia † 1  4/34 (11.76%)  4
Hypoglycemia † 1  1/34 (2.94%)  1
Hypokalemia † 1  3/34 (8.82%)  3
Hypomagnesemia † 1  1/34 (2.94%)  1
Hyponatremia † 1  3/34 (8.82%)  3
Hypophosphatemia † 1  1/34 (2.94%)  1
Musculoskeletal and connective tissue disorders   
Back pain † 1  1/34 (2.94%)  2
Chest wall pain † 1  1/34 (2.94%)  1
Joint pain † 1  1/34 (2.94%)  2
Muscle weakness † 1  2/34 (5.88%)  3
Myalgia † 1  2/34 (5.88%)  6
Myositis † 1  1/34 (2.94%)  1
Pain in extremity † 1  1/34 (2.94%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain † 1  1/34 (2.94%)  1
Nervous system disorders   
Dizziness † 1  4/34 (11.76%)  5
Headache † 1  1/34 (2.94%)  2
Memory impairment † 1  1/34 (2.94%)  4
Peripheral sensory neuropathy † 1  6/34 (17.65%)  30
Syncope † 1  1/34 (2.94%)  1
Syncope vasovagal † 1  1/34 (2.94%)  1
Taste alteration † 1  10/34 (29.41%)  37
Psychiatric disorders   
Anxiety † 1  4/34 (11.76%)  10
Confusion † 1  1/34 (2.94%)  4
Depression † 1  2/34 (5.88%)  4
Insomnia † 1  2/34 (5.88%)  3
Renal and urinary disorders   
Proteinuria † 1  13/34 (38.24%)  30
Respiratory, thoracic and mediastinal disorders   
Cough † 1  5/34 (14.71%)  8
Dyspnea † 1  9/34 (26.47%)  13
Hemorrhage nasal † 1  1/34 (2.94%)  2
Respiratory tract hemorrhage † 1  1/34 (2.94%)  1
Skin and subcutaneous tissue disorders   
Alopecia † 1  3/34 (8.82%)  6
Hand-and-foot syndrome † 1  1/34 (2.94%)  5
Rash desquamating † 1  12/34 (35.29%)  32
Vascular disorders   
Hypertension † 1  27/34 (79.41%)  70
Vascular disorder † 1  1/34 (2.94%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
[Not Specified]
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: Julian Molina, M.D, Ph.D.
Organization: Mayo Clinic
EMail: Molina.julian@mayo.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459862    
Other Study ID Numbers: NCI-2009-00656
NCI-2009-00656 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000539269
N0623 ( Other Identifier: North Central Cancer Treatment Group )
N0623 ( Other Identifier: CTEP )
U10CA025224 ( U.S. NIH Grant/Contract )
First Submitted: April 11, 2007
First Posted: April 13, 2007
Results First Submitted: October 7, 2013
Results First Posted: December 5, 2013
Last Update Posted: February 24, 2015