Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02729194|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: Pazopanib Other: Low Fat Diet||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||April 2020|
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) approximately, some sample meals are described in appendix 1) 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.
Other: Low Fat Diet
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.
- Number of Grade 3 or 4 Adverse Events [ Time Frame: Time of initial study treatment to 30 days post treatment ]Frequency of grade 3 or 4 adverse events associated with pazopanib administered with a low fat meal by CTCAE version 4.0.
- Number of Dose Reductions [ Time Frame: 2 Years ]The frequency of dose reductions.
- Duration of Treatment [ Time Frame: 2 Years ]
- Mean Total Dose [ Time Frame: 2 Years ]
- Number of Patients that Respond to Treatment (Overall Response) with Pazopanib Administered Along with a Low Fat Diet [ Time Frame: 12 Weeks after start of study treatment ]To estimate the overall response proportion to pazopanib administered with a low fat meal by RECIST 1.1 criteria.
- Number of Patients with Complete Response [ Time Frame: 12 Weeks after start of study treatment ]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.
- Number of Patients with Partial Response [ Time Frame: 12 Weeks after start of study treatment ]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.
- Progression-Free Survival Time [ Time Frame: 2 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729194
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ajjai Alva, M.D.||University of Michigan Cancer Center|