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Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (MRCC RCC)

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ClinicalTrials.gov Identifier: NCT00706706
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : December 20, 2012
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Renal Cell
Intervention Drug: Sunitinib Malate (SU011248)
Enrollment 105

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
Period Title: Overall Study
Started 105
Completed 0
Not Completed 105
Reason Not Completed
Death             53
Lost to Follow-up             7
Study endpoint had reached             45
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
Overall Number of Baseline Participants 105
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants
54.6  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
26
  24.8%
Male
79
  75.2%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Time Frame Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included those participants who had taken at least one dose of the study drug.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
Overall Number of Participants Analyzed 105
Median (95% Confidence Interval)
Unit of Measure: Weeks
61.7
(45.1 to 106.3)
2.Secondary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time Frame Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included those participants who had the disease under study, measurable disease and an adequate baseline disease assessment and had taken at least one dose of the study drug.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
Overall Number of Participants Analyzed 103
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
31.1
(22.3 to 40.9)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included those participants who had taken at least one dose of the study drug.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
Overall Number of Participants Analyzed 105
Median (95% Confidence Interval)
Unit of Measure: Weeks
133.4 [1] 
(94.1 to NA)
[1]
Upper limit of confidence interval was not estimable due to the high number of participants censored for survival.
4.Secondary Outcome
Title One Year Survival Probability
Hide Description One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.
Time Frame Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included those participants who had taken at least one dose of the study drug.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent chance of survival
72.0
(62.3 to 79.7)
Time Frame AEs/SAEs: From signing of informed consent form up to 28 days after last dose
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sunitinib
Hide Arm/Group Description Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%)
Total   13/105 (12.38%) 
Cardiac disorders   
Right ventricular dysfunction * 1  1/105 (0.95%) 
General disorders   
Death * 1  1/105 (0.95%) 
Disease progression * 1  3/105 (2.86%) 
Infections and infestations   
Pneumonia * 1  2/105 (1.90%) 
Investigations   
Blood creatinine increased * 1  1/105 (0.95%) 
Platelet count decreased * 1  1/105 (0.95%) 
Nervous system disorders   
Cerebral haemorrhage * 1  1/105 (0.95%) 
Renal and urinary disorders   
Haematuria * 1  1/105 (0.95%) 
Renal failure * 1  1/105 (0.95%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia * 1  1/105 (0.95%) 
Pneumothorax * 1  1/105 (0.95%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib
Affected / at Risk (%)
Total   102/105 (97.14%) 
Blood and lymphatic system disorders   
Anaemia * 1  9/105 (8.57%) 
Leukopenia * 1  29/105 (27.62%) 
Lymphopenia * 1  9/105 (8.57%) 
Neutropenia * 1  8/105 (7.62%) 
Thrombocytopenia * 1  24/105 (22.86%) 
Endocrine disorders   
Hypothyroidism * 1  26/105 (24.76%) 
Eye disorders   
Eyelid oedema * 1  24/105 (22.86%) 
Gastrointestinal disorders   
Abdominal distension * 1  13/105 (12.38%) 
Abdominal pain upper * 1  10/105 (9.52%) 
Constipation * 1  8/105 (7.62%) 
Diarrhoea * 1  51/105 (48.57%) 
Dry mouth * 1  9/105 (8.57%) 
Dyspepsia * 1  19/105 (18.10%) 
Gastrooesophageal reflux disease * 1  6/105 (5.71%) 
Haemorrhoids * 1  7/105 (6.67%) 
Mouth ulceration * 1  30/105 (28.57%) 
Nausea * 1  15/105 (14.29%) 
Stomatitis * 1  18/105 (17.14%) 
Toothache * 1  8/105 (7.62%) 
Vomiting * 1  10/105 (9.52%) 
General disorders   
Chest pain * 1  8/105 (7.62%) 
Face oedema * 1  24/105 (22.86%) 
Fatigue * 1  54/105 (51.43%) 
Mucosal inflammation * 1  6/105 (5.71%) 
Oedema * 1  8/105 (7.62%) 
Oedema peripheral * 1  13/105 (12.38%) 
Pyrexia * 1  9/105 (8.57%) 
Investigations   
Alanine aminotransferase increased * 1  17/105 (16.19%) 
Aspartate aminotransferase increased * 1  16/105 (15.24%) 
Blood bilirubin increased * 1  10/105 (9.52%) 
Blood calcium decreased * 1  9/105 (8.57%) 
Blood creatinine increased * 1  19/105 (18.10%) 
Blood glucose increased * 1  6/105 (5.71%) 
Blood phosphorus decreased * 1  6/105 (5.71%) 
Blood thyroid stimulating hormone increased * 1  26/105 (24.76%) 
Blood urea increased * 1  9/105 (8.57%) 
Blood uric acid increased * 1  8/105 (7.62%) 
Haemoglobin decreased * 1  39/105 (37.14%) 
Lymphocyte count decreased * 1  8/105 (7.62%) 
Lymphocyte count increased * 1  9/105 (8.57%) 
Neutrophil count decreased * 1  41/105 (39.05%) 
Platelet count decreased * 1  54/105 (51.43%) 
Thyroxine increased * 1  6/105 (5.71%) 
Weight decreased * 1  23/105 (21.90%) 
White blood cell count decreased * 1  55/105 (52.38%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  45/105 (42.86%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  14/105 (13.33%) 
Pain in extremity * 1  7/105 (6.67%) 
Nervous system disorders   
Dizziness * 1  13/105 (12.38%) 
Dysgeusia * 1  29/105 (27.62%) 
Headache * 1  6/105 (5.71%) 
Psychiatric disorders   
Insomnia * 1  6/105 (5.71%) 
Renal and urinary disorders   
Proteinuria * 1  8/105 (7.62%) 
Reproductive system and breast disorders   
Genital rash * 1  6/105 (5.71%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  8/105 (7.62%) 
Epistaxis * 1  11/105 (10.48%) 
Oropharyngeal pain * 1  7/105 (6.67%) 
Skin and subcutaneous tissue disorders   
Dermatitis * 1  7/105 (6.67%) 
Hair colour changes * 1  11/105 (10.48%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  67/105 (63.81%) 
Rash * 1  28/105 (26.67%) 
Skin discolouration * 1  14/105 (13.33%) 
Swelling face * 1  6/105 (5.71%) 
Yellow skin * 1  15/105 (14.29%) 
Vascular disorders   
Hypertension * 1  39/105 (37.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v14.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00706706     History of Changes
Other Study ID Numbers: A6181132
First Submitted: June 25, 2008
First Posted: June 27, 2008
Results First Submitted: August 24, 2012
Results First Posted: December 20, 2012
Last Update Posted: January 18, 2013