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Trial · NCT02729194

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

NCT02729194, Early phase 1, Completed, University of Michigan Rogel Cancer Center; results first posted 2019-06-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma. Trials, record NCT02729194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02729194

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma
NCT number
NCT02729194
Status
Completed
Phases
Early phase 1
Enrollment
16 participants, actual
Lead sponsor
University of Michigan Rogel Cancer Center
Conditions
Carcinoma, Renal Cell
Interventions
Pazopanib, Low Fat Diet
First posted
2016-04-06
Last updated
2019-06-10
Results first posted
2019-06-10

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Grade 3 or 4 Adverse EventsThrough 12 weeks of treatment to 30 days post-treatmentNumber of grade 3 or 4 adverse events associated with pazopanib administered with a low fat meal by CTCAE version 4.0.
PrimaryNumber of Participants With Dose Reductions12 weeks
PrimaryDuration of Treatment12 weeksThe median duration of treatment will be reported.
PrimaryMedian Total Dose12 weeksMedian total dose given.
SecondaryPercentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet12 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. 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.
SecondaryNumber of Participants With Complete Response12 Weeks after start of study treatmentComplete 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.
SecondaryNumber of Patients With Partial Response12 Weeks after start of study treatmentPartial 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.

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Grade 3 or 4 Adverse EventsThrough 12 weeks of treatment to 30 days post-treatment16 participants were enrolled and treated.adverse eventsNUMBER
PRIMARYNumber of Participants With Dose Reductions12 weeks16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYDuration of Treatment12 weeks16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.weeksMEDIAN
PRIMARYMedian Total Dose12 weeks16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.mgMEDIAN
SECONDARYPercentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet12 Weeks after start of study treatment16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.percentage of participantsNUMBER
SECONDARYNumber of Participants With Complete Response12 Weeks after start of study treatment16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients With Partial Response12 Weeks after start of study treatment16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.ParticipantsCOUNT_OF_PARTICIPANTS

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Grade 3 or 4 Adverse EventsPazopanibGrade 3 adverse events associated with treatment5adverse events
Number of Grade 3 or 4 Adverse EventsPazopanibGrade 4 adverse events associated with treatment0adverse events
Number of Participants With Dose ReductionsPazopanib3Participants
Duration of TreatmentPazopanib12Full Range 1 to 12weeks
Median Total DosePazopanib42,700Full Range 1200 to 63,200mg
Percentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat DietPazopanib38.4695% Confidence Interval 11 to 59percentage of participants
Number of Participants With Complete ResponsePazopanib0Participants
Number of Patients With Partial ResponsePazopanib5Participants

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPazopanib16
Overall StudyCOMPLETEDPazopanib13
Overall StudyNOT COMPLETEDPazopanib3

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnemiaBlood and lymphatic system disordersPazopanib1161
otherChest pain - cardiacCardiac disordersPazopanib1161
otherSick sinus syndromeCardiac disordersPazopanib1161
otherMiddle ear inflammationEar and labyrinth disordersPazopanib1161
otherEndocrine disorders - OtherEndocrine disordersPazopanib1161
otherHyperthyroidismEndocrine disordersPazopanib2162
otherHypothyroidismEndocrine disordersPazopanib1161
otherBlurred visionEye disordersPazopanib1161
otherAbdominal painGastrointestinal disordersPazopanib2162
otherConstipationGastrointestinal disordersPazopanib2162

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPazopanib016
Total, other adverse eventsPazopanib1516
Total, serious adverse eventsPazopanib116

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30393825DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02729194

GET https://conductscience.org/api/trials/v1/NCT02729194/events?page=2