Trial Outcomes & Findings for Neoadjuvant Pazopanib in Renal Cell Carcinoma (NCT NCT01361113)
NCT ID: NCT01361113
Last Updated: 2018-04-25
Results Overview
Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma. Evaluation of Target Lesions using RECIST 1.1 Criteria: Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to \<10mm. Partial response (PR)-At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD.
COMPLETED
PHASE2
21 participants
8 weeks after neoadjuvant treatment
2018-04-25
Participant Flow
28 patients consented to participate in this study; 6 patients were found ineligible and 1 patient refused treatment leaving 21 patients on study.
Participant milestones
| Measure |
Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Pazopanib in Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Single Arm Neoadjuvant Pazopanib
n=21 Participants
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|
|
Age, Continuous
|
61.57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after neoadjuvant treatmentDetermine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma. Evaluation of Target Lesions using RECIST 1.1 Criteria: Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to \<10mm. Partial response (PR)-At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Single Arm Neoadjuvant Pazopanib
n=21 Participants
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
2 Year Recurrence Free Survival
Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|---|
|
Response Rate
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsEstimate recurrence free survival (RFS) following neoadjuvant treatment with pazopanib followed by nephrectomy, specifically reporting the 1 year and 2 year rate estimates with their 95% confidence intervals.
Outcome measures
| Measure |
Single Arm Neoadjuvant Pazopanib
n=21 Participants
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
2 Year Recurrence Free Survival
n=21 Participants
Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|---|
|
Recurrence Free Survival (RFS)
|
83 percentage of Participants
Interval 57.0 to 94.0
|
77 percentage of Participants
Interval 49.0 to 91.0
|
SECONDARY outcome
Timeframe: 14 weeksDetermine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response.
Outcome measures
| Measure |
Single Arm Neoadjuvant Pazopanib
n=21 Participants
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
2 Year Recurrence Free Survival
Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|---|
|
Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 weeksIdentify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy. Number of patients that had adverse events reported that had an attribution of; possible, probable, or definite that are graded a 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event.
Outcome measures
| Measure |
Single Arm Neoadjuvant Pazopanib
n=21 Participants
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
2 Year Recurrence Free Survival
Single Arm Neoadjuvant Pazopanib
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|---|
|
Number of Participants With Adverse Events Related to Treatment.
|
11 Participants
|
—
|
Adverse Events
Single Arm Neoadjuvant Pazopanib
Serious adverse events
| Measure |
Single Arm Neoadjuvant Pazopanib
n=21 participants at risk
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • 9 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
1/21 • 9 weeks
|
|
Investigations
Cardiac troponin I increased
|
4.8%
1/21 • 9 weeks
|
|
Investigations
CPK increased
|
4.8%
1/21 • 9 weeks
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • 9 weeks
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
4.8%
1/21 • 9 weeks
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • 9 weeks
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
1/21 • 9 weeks
|
|
Vascular disorders
Thromboembolic event
|
4.8%
1/21 • 9 weeks
|
Other adverse events
| Measure |
Single Arm Neoadjuvant Pazopanib
n=21 participants at risk
Pazopanib 800 mg PO once daily for 8 weeks
Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • 9 weeks
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
7/21 • 9 weeks
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
1/21 • 9 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
9.5%
2/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
6/21 • 9 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
38.1%
8/21 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • 9 weeks
|
|
Gastrointestinal disorders
Bloating
|
4.8%
1/21 • 9 weeks
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
4.8%
1/21 • 9 weeks
|
|
Investigations
Blood bilirubin increased
|
19.0%
4/21 • 9 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
4.8%
1/21 • 9 weeks
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
4.8%
1/21 • 9 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.8%
1/21 • 9 weeks
|
|
Psychiatric disorders
Confusion
|
4.8%
1/21 • 9 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • 9 weeks
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • 9 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
52.4%
11/21 • 9 weeks
|
|
Nervous system disorders
Dizziness
|
19.0%
4/21 • 9 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
1/21 • 9 weeks
|
|
Nervous system disorders
Dysgeusia
|
52.4%
11/21 • 9 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • 9 weeks
|
|
General disorders
Fatigue
|
76.2%
16/21 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.5%
2/21 • 9 weeks
|
|
General disorders
Flu like symptoms
|
4.8%
1/21 • 9 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
4.8%
1/21 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
1/21 • 9 weeks
|
|
Investigations
GGT increased
|
9.5%
2/21 • 9 weeks
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • 9 weeks
|
|
Renal and urinary disorders
Hematuria
|
4.8%
1/21 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.8%
1/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.8%
1/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
1/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.5%
2/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.8%
1/21 • 9 weeks
|
|
Vascular disorders
Hypertension
|
61.9%
13/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.5%
2/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21 • 9 weeks
|
|
Endocrine disorders
Hypothyroidism
|
19.0%
4/21 • 9 weeks
|
|
Investigations
Lymphocyte count decreased
|
4.8%
1/21 • 9 weeks
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.8%
1/21 • 9 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
4.8%
1/21 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
42.9%
9/21 • 9 weeks
|
|
General disorders
Non-cardiac chest pain
|
4.8%
1/21 • 9 weeks
|
|
Gastrointestinal disorders
Oral dysesthesia
|
19.0%
4/21 • 9 weeks
|
|
General disorders
Pain
|
9.5%
2/21 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
28.6%
6/21 • 9 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
4.8%
1/21 • 9 weeks
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • 9 weeks
|
|
Nervous system disorders
Presyncope
|
4.8%
1/21 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
3/21 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
1/21 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
4.8%
1/21 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
14.3%
3/21 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.8%
1/21 • 9 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
4.8%
1/21 • 9 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
1/21 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
9.5%
2/21 • 9 weeks
|
|
Gastrointestinal disorders
Vomiting
|
23.8%
5/21 • 9 weeks
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60