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Trial record 43 of 794 for:    LENALIDOMIDE AND cells

Study of Lenalidomide in Combination With Sunitinib to Evaluate the Safety and Efficacy in Patients With Renal Cell Carcinoma

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: NCT00975806
Recruitment Status : Terminated (MTD determined sub-optimal as efficacious treatment for renal cell carcinoma.)
First Posted : September 11, 2009
Results First Posted : December 29, 2014
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Interventions Drug: Lenalidomide
Drug: Sunitinib
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg
Hide Arm/Group Description Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Period Title: Overall Study
Started 5 7 4
Completed 0 [1] 0 [1] 0 [1]
Not Completed 5 7 4
Reason Not Completed
Adverse Event             2             1             2
Disease Progression             1             5             1
Withdrawal by Subject             1             0             0
Death             0             1             0
Physician decision and disease related             1             0             1
[1]
Participants were prematurely discontinued
Arm/Group Title Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg Total
Hide Arm/Group Description Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle Total of all reporting groups
Overall Number of Baseline Participants 5 7 4 16
Hide Baseline Analysis Population Description
Safety Population includes all participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 7 participants 4 participants 16 participants
55.0  (18.84) 57.1  (4.88) 57.3  (5.62) 56.5  (10.56)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 4 participants 16 participants
≤65 years 4 7 4 15
>65 years 1 0 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 4 participants 16 participants
Female
2
  40.0%
4
  57.1%
2
  50.0%
8
  50.0%
Male
3
  60.0%
3
  42.9%
2
  50.0%
8
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 4 participants 16 participants
Caucasian (White) 4 6 4 14
Black or African American 1 0 0 1
Unknown 0 1 0 1
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 7 participants 4 participants 16 participants
0 = fully active 4 4 4 12
1 = restricted activity but ambulatory 1 3 0 4
3 (Limited Self-Care) 0 0 0 0
4 (Completely Disabled) 0 0 0 0
[1]
Measure Description:

ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.

0 = Fully Active (Most Favorable Activity)

  1. = Restricted activity but ambulatory
  2. = Ambulatory but unable to carry out work activities
  3. = Limited Self-Care
  4. = Completely Disabled, No self-care (Least Favorable Activity)
1.Primary Outcome
Title Phase 1: Maximum Tolerated Dose (MTD)
Time Frame Within 21 days of first dose of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least one dose of the study drug.
Arm/Group Title Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg
Hide Arm/Group Description:
Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: mg
10
2.Primary Outcome
Title Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Hide Description

Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:

  • Complete response-disappearance of all lesions
  • Partial response-30% decrease in the sum of diameters of target lesions from baseline
  • Stable disease-neither shrinkage nor increase of lesions.
  • Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.
Time Frame After at least 3 cycles of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.
Arm/Group Title Phase 2: Lenalidomide 10mg and Sunitinib 37.5 mg
Hide Arm/Group Description:
Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib
Hide Description Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death
Time Frame First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least one dose of study drug.
Arm/Group Title Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg
Hide Arm/Group Description:
Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Number of Participants Analyzed 5 7 4
Measure Type: Number
Unit of Measure: participants
Participants with at least 1 TEAE 5 7 4
Participants with at least 1 serious TEAE 3 4 2
≥ 1 TEAE leading to stopping lenalidomide 2 2 2
≥ 1 TEAE leading to stopping sunitinib 2 2 2
≥ 1 TEAE -> dose reduction/interrruption of Len 5 6 4
≥ 1 TEAE dose reduction/interrruption of Sunitinib 5 5 3
Participants with ≥1 TEAE related to lenalidomide 5 7 4
Participants with ≥1 TEAE related to Sunitinib 5 7 4
≥ 1 NCI CTC Gr 3 or higher TEAE 5 6 4
≥ 1 NCI CTC Gr 3 or higher related to lenalidomide 4 5 4
≥ 1 NCI CTC Gr 3 or higher related to Sunitinib 4 5 4
≥ 1 serious TEAE related to lenalidomide 2 2 0
≥ 1 serious TEAE related to sunitinib 1 2 2
4.Secondary Outcome
Title Phase 1 : Tumor Response Rate According to RECIST 1.1
Hide Description

Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria:

Treatment response includes both complete response and partial response

  • Complete response-disappearance of all lesions
  • Partial response-30% decrease in the sum of diameters of target lesions from baseline
  • Stable disease-neither shrinkage nor increase of lesions
  • Progressive Disease-20% increase in the sum of diameters of target lesions from nadir
Time Frame Every 3 cycles; up to month 25
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population includes participants who took at least one dose of study drug. Study participants with stable disease also reported.
Arm/Group Title Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg
Hide Arm/Group Description:
Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Number of Participants Analyzed 5 7 4
Measure Type: Number
Unit of Measure: participants
Complete Response 0 0 0
Partial Response 1 0 0
Stable Disease 1 3 3
5.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.
Time Frame Day 1 of study drug to disease progression or death
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including MTD, were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.
Arm/Group Title Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg
Hide Arm/Group Description:
Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)
Time Frame Day 1 of initial response date to progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.
Arm/Group Title Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg
Hide Arm/Group Description:
Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from the start of study drug therapy to death.
Time Frame Day 1 of study drug to death
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.
Arm/Group Title Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg
Hide Arm/Group Description:
Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued.
Adverse Event Reporting Description Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
 
Arm/Group Title Cohort A Cohort F Cohort G
Hide Arm/Group Description Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
All-Cause Mortality
Cohort A Cohort F Cohort G
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A Cohort F Cohort G
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/5 (60.00%)   4/7 (57.14%)   2/4 (50.00%) 
Blood and lymphatic system disorders       
Anaemia  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Leukopenia  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Neutropenia  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Thrombocytopenia  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Cardiac disorders       
Atrial Fibrillation  1  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Gastrointestinal disorders       
Intestinal Obstruction  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Pancreatitis  1  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
General disorders       
Asthenia  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
General Physical Health Deterioration  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Influenza Like Illness  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Immune system disorders       
Hypersensitivity  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Infections and infestations       
Device related infection  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Urinary Tract Infection  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pleural Effusion  1  1/5 (20.00%)  1/7 (14.29%)  0/4 (0.00%) 
Vascular disorders       
Deep Vein Thrombosis  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Cohort F Cohort G
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   7/7 (100.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  3/5 (60.00%)  3/7 (42.86%)  1/4 (25.00%) 
Leukopenia  2  2/5 (40.00%)  1/7 (14.29%)  3/4 (75.00%) 
Neutropenia  2  2/5 (40.00%)  4/7 (57.14%)  2/4 (50.00%) 
Thrombocytpenia  2  2/5 (40.00%)  2/7 (28.57%)  1/4 (25.00%) 
Lymphopenia  2  1/5 (20.00%)  1/7 (14.29%)  1/4 (25.00%) 
Haemogloinaemia  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Cardiac disorders       
Splinter Haemorrhages  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Palpitations  1  0/5 (0.00%)  0/7 (0.00%)  2/4 (50.00%) 
Endocrine disorders       
Hypothyroidism  2  1/5 (20.00%)  1/7 (14.29%)  0/4 (0.00%) 
Thyroiditis Subacute  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Eye disorders       
Lacrimation Increased  1  1/5 (20.00%)  1/7 (14.29%)  0/4 (0.00%) 
Eye Swelling  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Periorbital oedema  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Tear discolouration  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  2  5/5 (100.00%)  3/7 (42.86%)  2/4 (50.00%) 
Nausea  2  4/5 (80.00%)  4/7 (57.14%)  3/4 (75.00%) 
Vomiting  2  3/5 (60.00%)  3/7 (42.86%)  2/4 (50.00%) 
Constipation  2  2/5 (40.00%)  1/7 (14.29%)  2/4 (50.00%) 
Stomatitis  1  2/5 (40.00%)  1/7 (14.29%)  0/4 (0.00%) 
Dyspepsia  2  1/5 (20.00%)  2/7 (28.57%)  0/4 (0.00%) 
Gastrooesophageal Reflux Disease  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Glossodynia  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Abdominal Discomfort  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Dental Caries  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Dry Mouth  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Eructation  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Tongue Disorder  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Tongue Ulceration  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Abdominal Pain  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
General disorders       
Fatigue  2  3/5 (60.00%)  7/7 (100.00%)  4/4 (100.00%) 
Chills  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Mucosal Inflammation  2  1/5 (20.00%)  3/7 (42.86%)  1/4 (25.00%) 
Non-cardiac Chest Pain  2  1/5 (20.00%)  1/7 (14.29%)  1/4 (25.00%) 
Early Satiety  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Face Oedema  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Influenza Like Illness  2  0/5 (0.00%)  3/7 (42.86%)  0/4 (0.00%) 
Immune system disorders       
Seasonal Allergy  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Infections and infestations       
Infected Bites  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Urinary Tract Infection  2  0/5 (0.00%)  1/7 (14.29%)  1/4 (25.00%) 
Injury, poisoning and procedural complications       
Contusion  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Fall  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Post Procedural Complication  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Investigations       
Blood Creatinine Increased  2  2/5 (40.00%)  2/7 (28.57%)  1/4 (25.00%) 
Transaminases Increased  1  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%) 
Blood Alkaline Phosphatase Increased  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Blood Lactate Dehydrogenase Increased  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Neutrophil Count Decreased  2  1/5 (20.00%)  1/7 (14.29%)  2/4 (50.00%) 
White Blood Cell Count Decreased  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Alanine Aminotransferase Increased  2  0/5 (0.00%)  1/7 (14.29%)  1/4 (25.00%) 
Aspartate Aminotransferase Increased  2  0/5 (0.00%)  2/7 (28.57%)  2/4 (50.00%) 
Blood Alkaline Phosphatase  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Blood Bilirubin Increased  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Weight Decreased  2  0/5 (0.00%)  1/7 (14.29%)  1/4 (25.00%) 
Metabolism and nutrition disorders       
Dehydration  2  3/5 (60.00%)  0/7 (0.00%)  0/4 (0.00%) 
Hypoalbuminaemia  2  3/5 (60.00%)  2/7 (28.57%)  0/4 (0.00%) 
Decreasd Appetite  2  2/5 (40.00%)  2/7 (28.57%)  1/4 (25.00%) 
Hyponatraemia  2  2/5 (40.00%)  2/7 (28.57%)  0/4 (0.00%) 
Hyperkalaemia  2  1/5 (20.00%)  1/7 (14.29%)  1/4 (25.00%) 
Hyperuricaemia  1  1/5 (20.00%)  0/7 (0.00%)  1/4 (25.00%) 
Hypocalcaemia  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Anorexia  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Hyperglycaemia  1  0/5 (0.00%)  2/7 (28.57%)  1/4 (25.00%) 
Hypoglycaemia  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Hypokalaemia  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Hypophosphataemia  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Back Pain  2  1/5 (20.00%)  0/7 (0.00%)  1/4 (25.00%) 
Flank Pain  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Muscular Weakness  1  1/5 (20.00%)  1/7 (14.29%)  0/4 (0.00%) 
Nervous system disorders       
Dysgeusia  1  4/5 (80.00%)  4/7 (57.14%)  1/4 (25.00%) 
Dizziness  2  3/5 (60.00%)  1/7 (14.29%)  2/4 (50.00%) 
Headache  2  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%) 
Neuropathy Peripheral  2  1/5 (20.00%)  1/7 (14.29%)  1/4 (25.00%) 
Peripheral Sensory Neuropathy  2  1/5 (20.00%)  0/7 (0.00%)  1/4 (25.00%) 
Paraesthesia  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Psychiatric disorders       
Anxiety  2  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%) 
Depression  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Renal and urinary disorders       
Dysuria  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Proteinuria  2  1/5 (20.00%)  2/7 (28.57%)  0/4 (0.00%) 
Haematuria  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Haemoglobinuria  2  0/5 (0.00%)  1/7 (14.29%)  1/4 (25.00%) 
Reproductive system and breast disorders       
Scrotal Oedema  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  2  2/5 (40.00%)  1/7 (14.29%)  2/4 (50.00%) 
Dysphonia  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Dyspnoea  2  1/5 (20.00%)  2/7 (28.57%)  1/4 (25.00%) 
Orophryngeal Pain  2  1/5 (20.00%)  0/7 (0.00%)  1/4 (25.00%) 
Rhinorrhoea  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Pleural Effusion  1  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Upper Respiratory Tract Congestion  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Sputum Discoloured  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Throat Irritation  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  2/5 (40.00%)  0/7 (0.00%)  0/4 (0.00%) 
Hair Colour Changes  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Pruritus  2  1/5 (20.00%)  1/7 (14.29%)  1/4 (25.00%) 
Rash Maculo-papular  2  1/5 (20.00%)  0/7 (0.00%)  1/4 (25.00%) 
Scar Pain  1  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Dermatitis  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Dry Skin  2  0/5 (0.00%)  2/7 (28.57%)  0/4 (0.00%) 
Erythema  2  0/5 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Night Sweats  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Vascular disorders       
Hypertension  2  1/5 (20.00%)  2/7 (28.57%)  1/4 (25.00%) 
Hypotension  2  1/5 (20.00%)  0/7 (0.00%)  0/4 (0.00%) 
Flushing  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Hot Flush  2  0/5 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 14.0
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.
Multicenter publications must include input from investigators and Celgene, and agreement be established before publication. Results from a center cannot be submitted for publication prior to a multicenter publication unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene ≤ 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ≤ 90 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne McClain,Senior Manager
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialsdisclosure@celgene.com
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00975806     History of Changes
Other Study ID Numbers: CC-5013-RCC-001
First Submitted: September 9, 2009
First Posted: September 11, 2009
Results First Submitted: December 17, 2014
Results First Posted: December 29, 2014
Last Update Posted: May 31, 2017