Trial Outcomes & Findings for Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer (NCT NCT00459875)

NCT ID: NCT00459875

Last Updated: 2015-11-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2015-11-26

Participant Flow

Participant milestones

Measure	Sunitinib The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks. sunitinib malate
Overall Study STARTED	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Sunitinib The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks. sunitinib malate
Overall Study Ineligible participant	1
Overall Study Adverse Event	2

Baseline Characteristics

Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

Baseline characteristics by cohort

Measure	Sunitinib n=24 Participants The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks. sunitinib malate
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Sunitinib n=23 Participants The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks. sunitinib malate
Overall Objective Response Rate as Measured by RECIST Partial Response (PR)	1 participants
Overall Objective Response Rate as Measured by RECIST Stable Disease (SD)	16 participants
Overall Objective Response Rate as Measured by RECIST Progression of Disease (POD)	6 participants

Adverse Events

Sunitinib

Serious events: 11 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sunitinib n=23 participants at risk The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks. sunitinib malate
Blood and lymphatic system disorders Coagulation, other	4.3% 1/23 • Number of events 1
Blood and lymphatic system disorders Creatinine	8.7% 2/23 • Number of events 2
Metabolism and nutrition disorders Dehydration	4.3% 1/23 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	8.7% 2/23 • Number of events 3
General disorders Fever (in the absence of neutropenia)	4.3% 1/23 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	4.3% 1/23 • Number of events 1
Gastrointestinal disorders Hemorrhage, Abdomen Not Otherwise Specified (NOS)	4.3% 1/23 • Number of events 1
General disorders Nausea	4.3% 1/23 • Number of events 1
General disorders Pain - Abdomen NOS	4.3% 1/23 • Number of events 1
General disorders Pain - Back	4.3% 1/23 • Number of events 1
General disorders Pain - Other (specify)	4.3% 1/23 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	4.3% 1/23 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	4.3% 1/23 • Number of events 1
General disorders Rigors/chills	4.3% 1/23 • Number of events 1
Cardiac disorders Thrombosis/thrombus/embolism	8.7% 2/23 • Number of events 2
General disorders Vomiting	4.3% 1/23 • Number of events 1

Other adverse events

Measure	Sunitinib n=23 participants at risk The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks. sunitinib malate
Blood and lymphatic system disorders ALT, SGPT	13.0% 3/23 • Number of events 3
Blood and lymphatic system disorders AST, SGOT	21.7% 5/23 • Number of events 5
Blood and lymphatic system disorders Bilirubin (hyperbilirubinemia)	13.0% 3/23 • Number of events 3
Blood and lymphatic system disorders Creatinine	13.0% 3/23 • Number of events 3
General disorders Fatigue (asthenia, lethargy, malaise)	13.0% 3/23 • Number of events 3
Metabolism and nutrition disorders Glucose, high (hyperglycemia)	17.4% 4/23 • Number of events 4
Blood and lymphatic system disorders Hemoglobin	39.1% 9/23 • Number of events 9
Cardiac disorders Hypertension	8.7% 2/23 • Number of events 2
Blood and lymphatic system disorders Leukocytes (total WBC)	43.5% 10/23 • Number of events 10
Blood and lymphatic system disorders Lymphopenia	21.7% 5/23 • Number of events 5
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	39.1% 9/23 • Number of events 9
Metabolism and nutrition disorders Phosphate, low (hypophosphatemia)	13.0% 3/23 • Number of events 3
Blood and lymphatic system disorders Platelets	26.1% 6/23 • Number of events 6
Blood and lymphatic system disorders Potassium, high (hyperkalemia)	26.1% 6/23 • Number of events 6
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	13.0% 3/23 • Number of events 4
Metabolism and nutrition disorders Sodium, low (hyponatremia)	8.7% 2/23 • Number of events 2
Metabolism and nutrition disorders Thyroid function, high	21.7% 5/23 • Number of events 11

Additional Information

Dr. Robert Motzer

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4312

Email: motzerr@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place