Trial Outcomes & Findings for Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma (NCT NCT00731211)

Last Updated: 2015-05-20

Results Overview

Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

18 months

Results posted on

2015-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Pazopanib 800 mg of pazopanib orally each day continuously Pazopanib: 800 mg of pazopanib orally each day continuously
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pazopanib in Previously Treated Patients With Metastatic Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib n=55 Participants 800 mg of pazopanib orally each day continuously Pazopanib: 800 mg of pazopanib orally each day continuously
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Pazopanib n=55 Participants 800 mg of pazopanib orally each day continuously Pazopanib: 800 mg of pazopanib orally each day continuously
Overall Response Rate	27 percentage of patients Interval 17.0 to 40.0

SECONDARY outcome

Timeframe: every 8 weeks until progressive disease, expected average of 18 months

Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Pazopanib n=55 Participants 800 mg of pazopanib orally each day continuously Pazopanib: 800 mg of pazopanib orally each day continuously
Progression-free Survival	7.5 months Interval 5.4 to 9.4

Adverse Events

Pazopanib

Serious events: 10 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pazopanib n=55 participants at risk 800 mg of pazopanib orally each day continuously Pazopanib: 800 mg of pazopanib orally each day continuously
Nervous system disorders Nervous system disorders - Other, speech impairment	1.8% 1/55
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.8% 1/55
Nervous system disorders Headache	1.8% 1/55
Gastrointestinal disorders Abdominal pain	1.8% 1/55
Psychiatric disorders Psychiatric disorders - Other, change in mental status	1.8% 1/55
Vascular disorders Hypertension	1.8% 1/55
Gastrointestinal disorders Gastrointestinal disorders - Other, hemorrhage	1.8% 1/55
Blood and lymphatic system disorders Anemia	1.8% 1/55
Vascular disorders Hematoma	1.8% 1/55
General disorders General disorders and administration site conditions - Other, failure to thrive	1.8% 1/55
Metabolism and nutrition disorders Dehydration	1.8% 1/55

Other adverse events

Other adverse events
Measure	Pazopanib n=55 participants at risk 800 mg of pazopanib orally each day continuously Pazopanib: 800 mg of pazopanib orally each day continuously
Investigations Alkaline phosphatase increased	9.1% 5/55
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.5% 3/55
Skin and subcutaneous tissue disorders Alopecia	9.1% 5/55
Investigations Alanine aminotransferase increased	25.5% 14/55
Metabolism and nutrition disorders Anorexia	34.5% 19/55
Investigations Aspartate aminotransferase increased	23.6% 13/55
Investigations Blood bilirubin increased	10.9% 6/55
Eye disorders Blurred vision	12.7% 7/55
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, burning skin	5.5% 3/55
Psychiatric disorders Confusion	7.3% 4/55
Gastrointestinal disorders Constipation	18.2% 10/55
Respiratory, thoracic and mediastinal disorders Cough	27.3% 15/55
Investigations Creatinine increased	23.6% 13/55
Metabolism and nutrition disorders Dehydration	14.5% 8/55
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	25.5% 14/55
Gastrointestinal disorders Diarrhea	61.8% 34/55
Nervous system disorders Dizziness	14.5% 8/55
Skin and subcutaneous tissue disorders Dry skin	7.3% 4/55
Gastrointestinal disorders Dysphagia	5.5% 3/55
Respiratory, thoracic and mediastinal disorders Dyspnea	32.7% 18/55
General disorders Edema face	12.7% 7/55
General disorders Edema limbs	30.9% 17/55
General disorders Fatigue	81.8% 45/55
General disorders Fever	10.9% 6/55
Gastrointestinal disorders Flatulence	7.3% 4/55
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, hair changes	5.5% 3/55
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	9.1% 5/55
Blood and lymphatic system disorders Anemia	41.8% 23/55
Gastrointestinal disorders Gastrointestinal disorders - Other, hemorrhage	7.3% 4/55
Respiratory, thoracic and mediastinal disorders Epistaxis	10.9% 6/55
Renal and urinary disorders Renal and urinary disorders - Other, urinary hemorrhage	5.5% 3/55
Metabolism and nutrition disorders Hyperglycemia	23.6% 13/55
Metabolism and nutrition disorders Hyperkalemia	12.7% 7/55
Vascular disorders Hypertension	40.0% 22/55
Metabolism and nutrition disorders Hypoalbuminemia	12.7% 7/55
Metabolism and nutrition disorders Hypocalcemia	9.1% 5/55
Metabolism and nutrition disorders Hypokalemia	5.5% 3/55
Metabolism and nutrition disorders Hyponatremia	10.9% 6/55
Skin and subcutaneous tissue disorders Skin hypopigmentation	12.7% 7/55
Infections and infestations Lip infection	5.5% 3/55
Infections and infestations Infections and infestations - Other, oral infection	7.3% 4/55
Infections and infestations Upper respiratory infection	10.9% 6/55
Psychiatric disorders Insomnia	14.5% 8/55
Investigations White blood cell decreased	10.9% 6/55
Nervous system disorders Memory impairment	7.3% 4/55
Psychiatric disorders Depression	10.9% 6/55
Gastrointestinal disorders Mucositis	21.8% 12/55
Gastrointestinal disorders Nausea	60.0% 33/55
Nervous system disorders Peripheral sensory neuropathy	27.3% 15/55
Gastrointestinal disorders Abdominal pain	36.4% 20/55
Musculoskeletal and connective tissue disorders Arthralgia	29.1% 16/55
Musculoskeletal and connective tissue disorders Back pain	34.5% 19/55
Musculoskeletal and connective tissue disorders Bone pain	14.5% 8/55
General disorders Non-cardiac chest pain	7.3% 4/55
Gastrointestinal disorders Toothache	5.5% 3/55
Nervous system disorders Headache	32.7% 18/55
Musculoskeletal and connective tissue disorders Pain in extremity	32.7% 18/55
Musculoskeletal and connective tissue disorders Myalgia	20.0% 11/55
Musculoskeletal and connective tissue disorders Neck pain	5.5% 3/55
General disorders Pain	9.1% 5/55
Gastrointestinal disorders Oral pain	9.1% 5/55
Investigations Platelet count decreased	25.5% 14/55
Renal and urinary disorders Proteinuria	45.5% 25/55
Skin and subcutaneous tissue disorders Pruritus	7.3% 4/55
Skin and subcutaneous tissue disorders Rash	32.7% 18/55
Gastrointestinal disorders Gastroesophageal reflux disease	18.2% 10/55
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, skin changes	20.0% 11/55
Nervous system disorders Nervous system disorders - Other, speech impairment	7.3% 4/55
Skin and subcutaneous tissue disorders Hyperhidrosis	9.1% 5/55
Nervous system disorders Dysgeusia	30.9% 17/55
Eye disorders Eye disorders - Other, vision changes	5.5% 3/55
Gastrointestinal disorders Vomiting	23.6% 13/55
Eye disorders Watering eyes	5.5% 3/55
Musculoskeletal and connective tissue disorders Generalized muscle weakness	18.2% 10/55
Investigations Weight loss	21.8% 12/55
Injury, poisoning and procedural complications Wound complication	5.5% 3/55

Additional Information

John D. Hainsworth, MD

Sarah Cannon Research Institute

Phone: 1-877-691-7274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Publication restrictions are in place

Restriction type: OTHER