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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02729194
First Posted: April 6, 2016
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Michigan Cancer Center
  Purpose
Pazopanib is an orally administered multi-kinase inhibitor targeting VEGFR (vascular endothelial growth factor receptor), PDGFR (platelet derived growth factor) and c-kit, which are critical to growth and proliferation of neoplastic cells. Pazopanib has been FDA approved for advanced renal cell carcinoma (RCC) with a clear cell component. Conventional Pazopanib dosing WITHOUT FOOD is with an initial dose of 800 mg by mouth daily. Investigators hypothesize that administration of pazopanib with low fat meal would be safe and feasible with secondary implications of higher pazopanib levels; potentially translating into greater anti-tumor efficacy in advanced renal cell cancer, with significant cost savings. In the proposed pilot study, investigators seek to test the feasibility and practicality of this approach and gather preliminary data on adverse effects and the safety profile. Investigators hope to ameliorate any potential for greater toxicities with a dynamic dosing design that incorporates adverse events from each cycle into dosing for the next cycle and a structured symptom specific plan.

Condition Intervention Phase
Carcinoma, Renal Cell Drug: Pazopanib Other: Low Fat Diet Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: June 2016
Estimated Study Completion Date: April 2020
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib
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.
Drug: Pazopanib 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years of age) with unresectable locally advanced or metastatic renal cell carcinoma with a clear cell component.
  • Subjects must have measurable disease per RECIST 1.1 criteria.
  • Subjects must not have had prior pazopanib therapy.
  • Subjects must have an ECOG (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.) performance status of less than or equal to 2.
  • Up to 3 lines of prior VEGF (vascular endothelial growth factor) or VEGFR (vascular endothelial growth factor receptor) targeted therapy are permitted. Any prior therapy should have been completed ≥ 2 weeks prior to start of study therapy.
  • Subjects may have received any number of the following therapies: cytokine therapy (e.g. high dose interleukin-2) or checkpoint inhibitor therapy (e.g. anti-PD1/PDL1, anti-CTLA4) or mTOR inhibitor therapy (e.g. everolimus, temsirolimus).
  • Adequate organ and marrow function (Absolute neutrophil count > 1000/mm3, platelets > 100,000/mm3, aspartate aminotransferase/ alanine aminotransferase/ total bilirubin < 1.5 X ULN (upper limit of normal). Patients with Gilbert's disease are exempt.
  • Subject must be willing and able to take pazopanib with a low-fat meal every day as specified in the protocol.
  • Subjects must be willing and able to come off any PPI(proton pump inhibitor)/other strong CYP3A4 inhibitors or inducers/simvastatin.
  • Ability to understand and the willingness to sign a written informed consent.
  • All subjects, including those who are surgically sterilized, must be willing to use an effective method of contraception.

Exclusion Criteria:

  • Any concurrent health condition that in the view of the treating physician would pose excessive risk to the patient if enrolled in the study.
  • Subjects with a history of hemoptysis, cerebral hemorrhage, clinically significant GI hemorrhage, myocardial infarction within the past 6 months.
  • Patients at significant risk for GI (gastrointestinal) perforation or fistula.
  • Pregnant or nursing mothers.
  • Untreated CNS (central nervous system) metastasis. If treated CNS metastasis/es, treatment of CNS disease (surgery or radiation) must have been completed at least 30 days prior to registration. Patients could still be on steroids.
  • Subjects with known history of Cirrhosis, HIV, Hepatitis B or C.
  • Averaged QTc baseline in 3 ECGs (electrocardiograms) at least 5 minutes apart of ≥450 ms.
  • Congestive Heart Failure (NYHA Class III/IV) or LVEF (left ventricular ejection fraction) <50% at baseline.
  • Uncontrolled hypertension (HTN) despite medical management (blood pressure (BP) ≥ 160/100.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Ajjai Alva, M.D. University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan 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
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Urologic Diseases