Trial · NCT01361113
Neoadjuvant Pazopanib in Renal Cell Carcinoma
NCT01361113, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Pazopanib in Renal Cell Carcinoma. Trials, record NCT01361113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01361113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Pazopanib in Renal Cell Carcinoma
- NCT number
- NCT01361113
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Renal Cell Carcinoma
- Interventions
- Pazopanib
- First posted
- 2011-05-26
- Last updated
- 2018-04-25
- Results first posted
- 2017-05-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | 8 weeks after neoadjuvant treatment | Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma. Evaluation of Target Lesions using RECIST 1.1 Criteria: Complete response (CR)-Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to \<10mm. Partial response (PR)-At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD. |
| Secondary | Recurrence Free Survival (RFS) | 2 years | Estimate recurrence free survival (RFS) following neoadjuvant treatment with pazopanib followed by nephrectomy, specifically reporting the 1 year and 2 year rate estimates with their 95% confidence intervals. |
| Secondary | Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib | 14 weeks | Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response. |
| Secondary | Number of Participants With Adverse Events Related to Treatment. | 9 weeks | Identify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy. Number of patients that had adverse events reported that had an attribution of; possible, probable, or definite that are graded a 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | 8 weeks after neoadjuvant treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Recurrence Free Survival (RFS) | 2 years | percentage of Participants | NUMBER | |
| SECONDARY | Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib | 14 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events Related to Treatment. | 9 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Single Arm Neoadjuvant Pazopanib | 8 | Participants | ||
| Recurrence Free Survival (RFS) | 1 Year Recurrence Free Survival | 83 | 95% Confidence Interval 57 to 94 | percentage of Participants | |
| Recurrence Free Survival (RFS) | 2 Year Recurrence Free Survival | 77 | 95% Confidence Interval 49 to 91 | percentage of Participants | |
| Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib | Single Arm Neoadjuvant Pazopanib | 0 | Participants | ||
| Number of Participants With Adverse Events Related to Treatment. | Single Arm Neoadjuvant Pazopanib | 11 | 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 | Single Arm Neoadjuvant Pazopanib | 21 | |
| Overall Study | COMPLETED | Single Arm Neoadjuvant Pazopanib | 21 | |
| Overall Study | NOT COMPLETED | Single Arm Neoadjuvant Pazopanib | 0 |
Source ClinicalTrials.gov
Adverse events71
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 | Abdominal pain | Gastrointestinal disorders | Single Arm Neoadjuvant Pazopanib | 2 | 21 | |
| other | Alanine aminotransferase increased | Investigations | Single Arm Neoadjuvant Pazopanib | 7 | 21 | |
| other | Alkaline phosphatase increased | Investigations | Single Arm Neoadjuvant Pazopanib | 1 | 21 | |
| other | Anemia | Blood and lymphatic system disorders | Single Arm Neoadjuvant Pazopanib | 2 | 21 | |
| other | Anorexia | Metabolism and nutrition disorders | Single Arm Neoadjuvant Pazopanib | 6 | 21 | |
| other | Aspartate aminotransferase increased | Investigations | Single Arm Neoadjuvant Pazopanib | 8 | 21 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Single Arm Neoadjuvant Pazopanib | 2 | 21 | |
| other | Bloating | Gastrointestinal disorders | Single Arm Neoadjuvant Pazopanib | 1 | 21 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Single Arm Neoadjuvant Pazopanib | 1 | 21 | |
| other | Blood bilirubin increased | Investigations | Single Arm Neoadjuvant Pazopanib | 4 | 21 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm Neoadjuvant Pazopanib | 2 | 21 |
| Total, other adverse events | Single Arm Neoadjuvant Pazopanib | 21 | 21 |
| Total, serious adverse events | Single Arm Neoadjuvant Pazopanib | 6 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01361113
GET https://conductscience.org/api/trials/v1/NCT01361113/events?page=2