Trial Outcomes & Findings for Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab (NCT NCT00866320)
NCT ID: NCT00866320
Last Updated: 2014-07-23
Results Overview
The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.
COMPLETED
PHASE2
49 participants
at 8 weeks (2cycles of treatment)
2014-07-23
Participant Flow
This is a multiple site study. Patients were recruited 2/2006-4/2008 from medical hospitals in Cleveland, Ohio and Dallas, Texas
Participant milestones
| Measure |
Sorafenib
Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Sorafenib
Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab
Baseline characteristics by cohort
| Measure |
Sorafenib
n=49 Participants
Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 8 weeks (2cycles of treatment)Population: All patients who started treatment
The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.
Outcome measures
| Measure |
Sorafenib
n=47 Participants
Patients receive sorafenib twice a day until disease progression or toxicity.
|
|---|---|
|
Tumor Burden Reduction Rate (TBRR)
Achieved at least 5% tumor reduction
|
30 percentage of patients
|
|
Tumor Burden Reduction Rate (TBRR)
Did not achieve at least 5% tumor reduction
|
70 percentage of patients
|
SECONDARY outcome
Timeframe: followed until progression or death for approximately 3 yearsPopulation: All patients who started treatment
Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.
Outcome measures
| Measure |
Sorafenib
n=47 Participants
Patients receive sorafenib twice a day until disease progression or toxicity.
|
|---|---|
|
Overall Survival
|
16 months
Interval 7.6 to 32.3
|
SECONDARY outcome
Timeframe: followed to progression for approximately 3 yearsPopulation: All patients who started treatment
Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline. Progression-free survival measured in months and summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Sorafenib
n=47 Participants
Patients receive sorafenib twice a day until disease progression or toxicity.
|
|---|---|
|
Time to Progression
|
4.4 months
Interval 3.6 to 5.9
|
SECONDARY outcome
Timeframe: followed for overall response for approximately 3 yearsPopulation: Patients who achieved at least 5% tumor reduction
Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Outcome measures
| Measure |
Sorafenib
n=14 Participants
Patients receive sorafenib twice a day until disease progression or toxicity.
|
|---|---|
|
Duration of Overall Response (Tumor Burden Reduction)
|
7.1 months
Interval 2.1 to 9.2
|
Adverse Events
Sorafenib
Serious adverse events
| Measure |
Sorafenib
n=47 participants at risk
Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Constitutional Symptoms
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Pain
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Cardiac disorders
Thrombosis/embolism
|
2.1%
1/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
Other adverse events
| Measure |
Sorafenib
n=47 participants at risk
Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Vascular disorders
Hypertension
|
34.0%
16/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Edema
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Fatigue
|
53.2%
25/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Fever
|
6.4%
3/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Rigors, Chills
|
6.4%
3/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Weight Loss
|
21.3%
10/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.5%
12/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
29.8%
14/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
12.8%
6/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
59.6%
28/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-other
|
29.8%
14/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Endocrine disorders
Hypothyroidism
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Anorexia
|
36.2%
17/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Diarrhea
|
53.2%
25/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Taste Disturbance (dysgeusia)
|
14.9%
7/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Nausea
|
27.7%
13/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
27.7%
13/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
6/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Gastrointestinal disorders
Gastrointestinal-other
|
23.4%
11/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
General Disorders-other
|
6.4%
3/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-other
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Nervous system disorders
Headache
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
10.6%
5/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
General disorders
Pain-other
|
19.1%
9/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.4%
3/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
|
Reproductive system and breast disorders
Voice Changes/stridor/larynx
|
8.5%
4/47 • Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
|
Additional Information
Dr. Brian Rini
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place