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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Grade 3 or 4 Adverse Events | Through 12 weeks of treatment to 30 days post-treatment | Number of grade 3 or 4 adverse events associated with pazopanib administered with a low fat meal by CTCAE version 4.0. |
| Primary | Number of Participants With Dose Reductions | 12 weeks | |
| Primary | Duration of Treatment | 12 weeks | The median duration of treatment will be reported. |
| Primary | Median Total Dose | 12 weeks | Median total dose given. |
| Secondary | Percentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet | 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. 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. |
| Secondary | Number of Participants With Complete Response | 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. |
| Secondary | Number of Patients With Partial Response | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Grade 3 or 4 Adverse Events | Through 12 weeks of treatment to 30 days post-treatment | 16 participants were enrolled and treated. | adverse events | NUMBER |
| PRIMARY | Number of Participants With Dose Reductions | 12 weeks | 16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Duration of Treatment | 12 weeks | 16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol. | weeks | MEDIAN |
| PRIMARY | Median Total Dose | 12 weeks | 16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol. | mg | MEDIAN |
| SECONDARY | Percentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet | 12 Weeks after start of study treatment | 16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Complete Response | 12 Weeks after start of study treatment | 16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Partial Response | 12 Weeks after start of study treatment | 16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Grade 3 or 4 Adverse Events | Pazopanib | Grade 3 adverse events associated with treatment | 5 | adverse events | |
| Number of Grade 3 or 4 Adverse Events | Pazopanib | Grade 4 adverse events associated with treatment | 0 | adverse events | |
| Number of Participants With Dose Reductions | Pazopanib | 3 | Participants | ||
| Duration of Treatment | Pazopanib | 12 | Full Range 1 to 12 | weeks | |
| Median Total Dose | Pazopanib | 42,700 | Full Range 1200 to 63,200 | mg | |
| Percentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet | Pazopanib | 38.46 | 95% Confidence Interval 11 to 59 | percentage of participants | |
| Number of Participants With Complete Response | Pazopanib | 0 | Participants | ||
| Number of Patients With Partial Response | Pazopanib | 5 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib | 16 | |
| Overall Study | COMPLETED | Pazopanib | 13 | |
| Overall Study | NOT COMPLETED | Pazopanib | 3 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Pazopanib | 1 | 16 | 1 |
| other | Chest pain - cardiac | Cardiac disorders | Pazopanib | 1 | 16 | 1 |
| other | Sick sinus syndrome | Cardiac disorders | Pazopanib | 1 | 16 | 1 |
| other | Middle ear inflammation | Ear and labyrinth disorders | Pazopanib | 1 | 16 | 1 |
| other | Endocrine disorders - Other | Endocrine disorders | Pazopanib | 1 | 16 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Pazopanib | 2 | 16 | 2 |
| other | Hypothyroidism | Endocrine disorders | Pazopanib | 1 | 16 | 1 |
| other | Blurred vision | Eye disorders | Pazopanib | 1 | 16 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Pazopanib | 2 | 16 | 2 |
| other | Constipation | Gastrointestinal disorders | Pazopanib | 2 | 16 | 2 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib | 0 | 16 |
| Total, other adverse events | Pazopanib | 15 | 16 |
| Total, serious adverse events | Pazopanib | 1 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30393825 | DERIVED |
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.
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