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Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02729194
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Renal Cell
Interventions Drug: Pazopanib
Other: Low Fat Diet
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pazopanib
Hide Arm/Group Description Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Period Title: Overall Study
Started 16
Completed 13
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Pazopanib
Hide Arm/Group Description Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
Sixteen patients were enrolled in this study; three patients withdrew study consent prior to study completion.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
60
(47 to 75.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
4
  25.0%
Male
12
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
  93.8%
More than one race
0
   0.0%
Unknown or Not Reported
1
   6.3%
Baseline Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
0
11
  68.8%
1
5
  31.3%
[1]
Measure Description:

Baseline ECOG performance status. ECOG stands for Eastern Cooperative Oncology Group. The performance status is scale used by doctors and researchers to assess how the disease affects the daily living abilities of the patient.The scale ranges from 0 to 5 where 0 represents perfect health and 5 represents death.

0=Fully active, able to carry on all pre-disease performance without restriction

1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

Histology   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Pure Clear Cell
11
  68.8%
Mixed Histology
5
  31.3%
[1]
Measure Description: Renal cell carcinoma cellular histology at baseline.
Baseline Disease Site   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Lung
10
  62.5%
Adrenal
6
  37.5%
Pancreas
1
   6.3%
Liver
3
  18.8%
Bone
1
   6.3%
Nephrectomy bed
2
  12.5%
Retroperitoneal and perisplenic nodule
1
   6.3%
[1]
Measure Description: Sites of renal cell carcinoma metastasis at baseline.
Heng Criteria Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Favorable
3
  18.8%
Intermediate
13
  81.3%
Poor
0
   0.0%
[1]
Measure Description:

The Heng Score for Metastatic Renal Cell Carcinoma (RCC) prognosis determines overall survival in patients treated with VEGF–targeted therapy using a scoring system that assigned points based off of a number of criteria.

Score interpretation:

0=Favorable 1-2=Intermediate

≥3=Poor

Number of Prior Therapies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
No Prior Therapy
12
  75.0%
1 Prior Therapy
3
  18.8%
3 Prior Therapies
1
   6.3%
Prior Therapy Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Everolimus
1
   6.3%
High-dose IL-2
3
  18.8%
Sunitinib
1
   6.3%
Nivolumab
1
   6.3%
1.Primary Outcome
Title Number of Grade 3 or 4 Adverse Events
Hide Description Number of grade 3 or 4 adverse events associated with pazopanib administered with a low fat meal by CTCAE version 4.0.
Time Frame Through 12 weeks of treatment to 30 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
16 participants were enrolled and treated.
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: adverse events
Grade 3 adverse events associated with treatment 5
Grade 4 adverse events associated with treatment 0
2.Primary Outcome
Title Number of Participants With Dose Reductions
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
3
  23.1%
3.Primary Outcome
Title Duration of Treatment
Hide Description The median duration of treatment will be reported.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: weeks
12
(1 to 12)
4.Primary Outcome
Title Median Total Dose
Hide Description Median total dose given.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: mg
42,700
(1200 to 63,200)
5.Secondary Outcome
Title Percentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet
Hide Description

To estimate the overall response proportion to pazopanib administered with a low fat meal by RECIST 1.1 criteria. Overall response is defined as the number patients that experience Partial Response (PR) or Complete Response (CR).

CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

PR is defined as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.

Time Frame 12 Weeks after start of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.46
(11 to 59)
6.Secondary Outcome
Title Number of Participants With Complete Response
Hide Description Complete response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.
Time Frame 12 Weeks after start of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Number of Patients With Partial Response
Hide Description Partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.
Time Frame 12 Weeks after start of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.
Arm/Group Title Pazopanib
Hide Arm/Group Description:
Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
5
  38.5%
Time Frame Through 12 weeks of treatment up to 30 days post last treatment administration
Adverse Event Reporting Description Adverse Events (AEs) were collected beginning at treatment start through 30 days post last treatment administration.
 
Arm/Group Title Pazopanib
Hide Arm/Group Description Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal) every day in 14 day cycles, with a starting dose of 400 mg and adjusted for the next cycle (dose level +1:600 mg; dose level +2: 800 mg; dose level -1: 200 mg) based on toxicity assessment during or at the end of each cycle.
All-Cause Mortality
Pazopanib
Affected / at Risk (%)
Total   0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pazopanib
Affected / at Risk (%) # Events
Total   1/16 (6.25%)    
Vascular disorders   
Hypertension   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pazopanib
Affected / at Risk (%) # Events
Total   15/16 (93.75%)    
Blood and lymphatic system disorders   
Anemia   1/16 (6.25%)  1
Cardiac disorders   
Chest pain - cardiac   1/16 (6.25%)  1
Sick sinus syndrome   1/16 (6.25%)  1
Ear and labyrinth disorders   
Middle ear inflammation   1/16 (6.25%)  1
Endocrine disorders   
Endocrine disorders - Other   1/16 (6.25%)  1
Hyperthyroidism   2/16 (12.50%)  2
Hypothyroidism   1/16 (6.25%)  1
Eye disorders   
Blurred vision   1/16 (6.25%)  1
Gastrointestinal disorders   
Abdominal pain   2/16 (12.50%)  2
Constipation   2/16 (12.50%)  2
Diarrhea   10/16 (62.50%)  12
Flatulence   1/16 (6.25%)  1
Gastroesophageal reflux disease   1/16 (6.25%)  1
Mucositis oral   4/16 (25.00%)  4
Nausea   8/16 (50.00%)  8
Oral pain   2/16 (12.50%)  2
Vomiting   1/16 (6.25%)  1
General disorders   
Fatigue   7/16 (43.75%)  7
Pain   1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Wound complication   1/16 (6.25%)  1
Investigations   
Alanine aminotransferase increased   11/16 (68.75%)  13
Alkaline phosphatase increased   2/16 (12.50%)  2
Aspartate aminotransferase increased   12/16 (75.00%)  15
Blood bilirubin increased   2/16 (12.50%)  2
Creatinine increased   3/16 (18.75%)  3
Electrocardiogram QT corrected interval prolonged   1/16 (6.25%)  1
Lymphocyte count decreased   2/16 (12.50%)  2
Neutrophil count decreased   2/16 (12.50%)  2
Platelet count decreased   5/16 (31.25%)  7
Weight loss   1/16 (6.25%)  1
White blood cell decreased   5/16 (31.25%)  6
Metabolism and nutrition disorders   
Anorexia   2/16 (12.50%)  3
Hyperglycemia   8/16 (50.00%)  16
Hyperkalemia   5/16 (31.25%)  5
Hypoglycemia   2/16 (12.50%)  2
Hyponatremia   1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Myalgia   1/16 (6.25%)  1
Nervous system disorders   
Dysgeusia   3/16 (18.75%)  4
Headache   1/16 (6.25%)  1
Psychiatric disorders   
Insomnia   1/16 (6.25%)  1
Renal and urinary disorders   
Chronic kidney disease   1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   1/16 (6.25%)  1
Dyspnea   1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Alopecia   1/16 (6.25%)  1
Hypertrichosis   1/16 (6.25%)  1
Nail discoloration   1/16 (6.25%)  1
Palmar-plantar erythrodysesthesia syndrome   2/16 (12.50%)  2
Pruritus   1/16 (6.25%)  1
Rash acneiform   1/16 (6.25%)  1
Rash maculo-papular   2/16 (12.50%)  3
Skin hypopigmentation   1/16 (6.25%)  1
Vascular disorders   
Hypertension   9/16 (56.25%)  10
Hypotension   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ajjai Alva, M.D.
Organization: University of Michigan Rogel Cancer Center
Phone: 734-936-0091
EMail: ajjai@umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02729194     History of Changes
Other Study ID Numbers: UMCC 2016.013
HUM00111682 ( Other Identifier: University of Michigan )
First Submitted: March 22, 2016
First Posted: April 6, 2016
Results First Submitted: September 18, 2018
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019