Trial Outcomes & Findings for Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma (NCT NCT01100242)
NCT ID: NCT01100242
Last Updated: 2015-09-17
Results Overview
Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
36 weeks
Results posted on
2015-09-17
Participant Flow
Participant milestones
| Measure |
VELCADE and Sorafenib
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
VELCADE and Sorafenib
n=17 Participants
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
|
|---|---|
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Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 weeksProgression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 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
| Measure |
VELCADE and Sorafenib
n=17 Participants
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
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|---|---|
|
Progression Free Survival (PFS)
|
13.71 weeks
Interval 3.9 to 36.0
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SECONDARY outcome
Timeframe: 42 daysTumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the percentage of patients who achieve a CR or PR
Outcome measures
| Measure |
VELCADE and Sorafenib
n=17 Participants
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
|
|---|---|
|
Overall Response Rate (ORR)
Complete response (CR)
|
0 percentage of participants
|
|
Overall Response Rate (ORR)
Partial response (PR)
|
5.9 percentage of participants
|
|
Overall Response Rate (ORR)
Overall response rate (CR + PR)
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: 42 daysToxicity is assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Toxicity profile is reported as the number of patients who received at least one dose of on-study treatment and experienced a grade 3 or grade 4 adverse event (AE). For a more complete listing of all AEs experienced by patients on study, please see the Adverse Event section.
Outcome measures
| Measure |
VELCADE and Sorafenib
n=17 Participants
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
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|---|---|
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Toxicity Profile
Decreased platelets
|
1 participants
|
|
Toxicity Profile
Abdominal pain
|
2 participants
|
|
Toxicity Profile
Anorexia (loss of appetite)
|
2 participants
|
|
Toxicity Profile
Dehydration
|
1 participants
|
|
Toxicity Profile
Fatigue
|
2 participants
|
|
Toxicity Profile
Hand and foot syndrome
|
1 participants
|
|
Toxicity Profile
Hemoglobin
|
2 participants
|
|
Toxicity Profile
Hyperglycemia
|
1 participants
|
|
Toxicity Profile
Hypertension
|
1 participants
|
|
Toxicity Profile
Hypoalbuminemia
|
3 participants
|
|
Toxicity Profile
Hypokalemia
|
1 participants
|
|
Toxicity Profile
Hyponatremia
|
5 participants
|
|
Toxicity Profile
Hypophosphatemia
|
4 participants
|
|
Toxicity Profile
Lymphopenia
|
4 participants
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|
Toxicity Profile
Pain - Other (All over body)
|
1 participants
|
|
Toxicity Profile
Pain in extremity
|
1 participants
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|
Toxicity Profile
Weight loss
|
2 participants
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Adverse Events
VELCADE and Sorafenib
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VELCADE and Sorafenib
n=17 participants at risk
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
|
|---|---|
|
Hepatobiliary disorders
Pancreatitis
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Infections and infestations
Infection - Other
|
5.9%
1/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Chest pain
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Pain - other
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness of breath)
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Renal and urinary disorders
Urinary retention
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
Other adverse events
| Measure |
VELCADE and Sorafenib
n=17 participants at risk
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 \& 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
|
|---|---|
|
General disorders
Allergic reaction
|
5.9%
1/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Blood and lymphatic system disorders
Blood - Other
|
5.9%
1/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
47.1%
8/17 • Number of events 42 • Up to 42 days following last on-study treatment
|
|
Blood and lymphatic system disorders
Neutrophils decreased
|
23.5%
4/17 • Number of events 19 • Up to 42 days following last on-study treatment
|
|
Blood and lymphatic system disorders
Platelets decreased
|
82.4%
14/17 • Number of events 83 • Up to 42 days following last on-study treatment
|
|
Cardiac disorders
Hypertension
|
35.3%
6/17 • Number of events 7 • Up to 42 days following last on-study treatment
|
|
Cardiac disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Cardiac disorders
Arrhythmia supraventricular
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Ascites
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Fatigue
|
52.9%
9/17 • Number of events 18 • Up to 42 days following last on-study treatment
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Weight loss
|
29.4%
5/17 • Number of events 8 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.5%
4/17 • Number of events 4 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
17.6%
3/17 • Number of events 3 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
11.8%
2/17 • Number of events 3 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.5%
4/17 • Number of events 4 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.2%
7/17 • Number of events 11 • Up to 42 days following last on-study treatment
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Abdominal distention
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Anorexia
|
35.3%
6/17 • Number of events 7 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Number of events 3 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Dehydration
|
17.6%
3/17 • Number of events 3 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
41.2%
7/17 • Number of events 16 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Nausea
|
47.1%
8/17 • Number of events 11 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Taste alteration
|
23.5%
4/17 • Number of events 4 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Voice changes
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
3/17 • Number of events 4 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Gastrointestinal disorders
Cholecystitis
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Infections and infestations
Infection
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Infections and infestations
Infection, Dental-tooth
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Infections and infestations
Skin infection
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Infections and infestations
Tooth infection
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Edema limbs
|
29.4%
5/17 • Number of events 6 • Up to 42 days following last on-study treatment
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • Number of events 3 • Up to 42 days following last on-study treatment
|
|
Investigations
Alkaline phosphatase increased
|
23.5%
4/17 • Number of events 8 • Up to 42 days following last on-study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • Number of events 4 • Up to 42 days following last on-study treatment
|
|
Investigations
Creatinine increased
|
64.7%
11/17 • Number of events 26 • Up to 42 days following last on-study treatment
|
|
Investigations
Hyperbilirubinemia
|
17.6%
3/17 • Number of events 4 • Up to 42 days following last on-study treatment
|
|
Investigations
Hypercalcemia (high calcium levels in blood)
|
17.6%
3/17 • Number of events 4 • Up to 42 days following last on-study treatment
|
|
Investigations
Hyperglycemia (high glucose levels in blood)
|
70.6%
12/17 • Number of events 41 • Up to 42 days following last on-study treatment
|
|
Investigations
Hyperkalemia (high potassium levels in blood)
|
35.3%
6/17 • Number of events 13 • Up to 42 days following last on-study treatment
|
|
Investigations
Hypermagnesemia (high magnesium levels in blood)
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Investigations
Hypoalbuminemia (high albumin levels in blood)
|
70.6%
12/17 • Number of events 22 • Up to 42 days following last on-study treatment
|
|
Investigations
Hypocalcemia (low calcium levels in blood)
|
47.1%
8/17 • Number of events 28 • Up to 42 days following last on-study treatment
|
|
Investigations
Hypokalemia (low potassium levels in blood)
|
35.3%
6/17 • Number of events 26 • Up to 42 days following last on-study treatment
|
|
Investigations
Hypomagnesemia (low magnesium levels in blood)
|
17.6%
3/17 • Number of events 6 • Up to 42 days following last on-study treatment
|
|
Investigations
Hyponatremia (low sodium levels in blood)
|
70.6%
12/17 • Number of events 46 • Up to 42 days following last on-study treatment
|
|
Investigations
Hypophosphatemia (low phosphate levels in blood)
|
47.1%
8/17 • Number of events 28 • Up to 42 days following last on-study treatment
|
|
Blood and lymphatic system disorders
Leukocytes decreased
|
35.3%
6/17 • Number of events 56 • Up to 42 days following last on-study treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
41.2%
7/17 • Number of events 95 • Up to 42 days following last on-study treatment
|
|
Investigations
Metabolic/Lab - Other
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Investigations
Prothombin time increased
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - lower limb
|
5.9%
1/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 3 • Up to 42 days following last on-study treatment
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
35.3%
6/17 • Number of events 7 • Up to 42 days following last on-study treatment
|
|
General disorders
Ear, nose and throat examination abnormal
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Abdominal pain
|
29.4%
5/17 • Number of events 7 • Up to 42 days following last on-study treatment
|
|
General disorders
Back pain
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Chest pain
|
5.9%
1/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
General disorders
Chest wall pain
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
External ear pain
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Kidney pain
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
General disorders
Pain - Other
|
11.8%
2/17 • Number of events 2 • Up to 42 days following last on-study treatment
|
|
General disorders
Pain in extremity
|
29.4%
5/17 • Number of events 8 • Up to 42 days following last on-study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
|
Renal and urinary disorders
Urine discoloration
|
5.9%
1/17 • Number of events 1 • Up to 42 days following last on-study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place