Trial · NCT01392183
Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)
NCT01392183, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2021-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC). Trials, record NCT01392183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01392183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)
- NCT number
- NCT01392183
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Kidney Cancer
- Interventions
- Pazopanib, Temsirolimus, Quality of Life Assessment, Benadryl
- First posted
- 2011-07-12
- Last updated
- 2021-09-20
- Results first posted
- 2021-09-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Measured form start of treatment up to 3 years | PFS is measured from the initiation of treatment to the time of first disease progression or death due to any reason during the first drug administration in each arm. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameters of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions. The PFS median of first drug pazopanib (treatment group) was compared to the PFS median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard ratio compares events from a treatment group to a control group. If the hazard ratio is greater than 1the treatment group performed better. If the hazard ratio is less than 1 the control group performed better. If the hazard ratio is equal to 1, then the groups performed equally. |
| Secondary | Overall Survival (OS) | From the start of treatment up to 6 years or death, whichever came first | Overall survival is calculated from day of therapy initiation of the first administrated drug to the date of death. Kaplan-Meier estimator used to estimate the OS for each group of participants. The Overall Survival median of first drug pazopanib (treatment group) was compared to the Overall Survival median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard ratio compares events from a treatment group to a control group. If the hazard ratio is greater than 1the treatment group performed better. If the hazard ratio is less than 1 the control group performed better. If the hazard ratio is equal to 1, then the groups performed equally. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Measured form start of treatment up to 3 years | The ratio is comparing both arms to each other, therefore the data would be identical. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the start of treatment up to 6 years or death, whichever came first | The ratio is comparing both arms to each other, therefore the data would be identical. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Temsirolimus (Control Group) | 2.7 | Full Range 1.2 to 24.6 | months | |
| Progression Free Survival (PFS) | Pazopanib (Treatment Group) | 5.2 | Full Range 0.4 to 34.5 | months | |
| Overall Survival (OS) | Temsirolimus (Control Group) | 7.1 | Full Range 2.4 to 68.8 | months | |
| Overall Survival (OS) | Pazopanib (Treatment Group) | 11.9 | Full Range 1.3 to 63.4 | months |
Source ClinicalTrials.gov
Participant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Drug Administration | STARTED | Temsirolimus (Control Group) | 35 | |
| First Drug Administration | STARTED | Pazopanib (Treatment Group) | 34 | |
| First Drug Administration | Eligible to Cross Over to 2nd Drug | Temsirolimus (Control Group) | 29 | |
| First Drug Administration | Eligible to Cross Over to 2nd Drug | Pazopanib (Treatment Group) | 31 | |
| First Drug Administration | COMPLETED | Temsirolimus (Control Group) | 21 | |
| First Drug Administration | COMPLETED | Pazopanib (Treatment Group) | 15 | |
| First Drug Administration | NOT COMPLETED | Temsirolimus (Control Group) | 14 | |
| First Drug Administration | NOT COMPLETED | Pazopanib (Treatment Group) | 19 | |
| Second Drug Administration | STARTED | Temsirolimus (Control Group) | 21 | |
| Second Drug Administration | STARTED | Pazopanib (Treatment Group) | 15 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events158
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 | Temsirolimus (Control Group) | 4 | 50 | 5 |
| other | Abdominal Pain | Gastrointestinal disorders | Pazopanib (Treatment Group) | 8 | 55 | 12 |
| other | ALT Increased | Hepatobiliary disorders | Temsirolimus (Control Group) | 3 | 50 | |
| other | ALT Increased | Hepatobiliary disorders | Pazopanib (Treatment Group) | 19 | 55 | 47 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Temsirolimus (Control Group) | 8 | 50 | 10 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Pazopanib (Treatment Group) | 9 | 55 | 17 |
| other | Alk Phos Increased | Hepatobiliary disorders | Temsirolimus (Control Group) | 15 | 50 | 27 |
| other | Alk Phos Increased | Hepatobiliary disorders | Pazopanib (Treatment Group) | 17 | 55 | 35 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Temsirolimus (Control Group) | 2 | 50 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pazopanib (Treatment Group) | 5 | 55 | 8 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temsirolimus (Control Group) | 32 | 50 |
| Total, all-cause mortality | Pazopanib (Treatment Group) | 31 | 55 |
| Total, other adverse events | Temsirolimus (Control Group) | 35 | 50 |
| Total, other adverse events | Pazopanib (Treatment Group) | 33 | 55 |
| Total, serious adverse events | Temsirolimus (Control Group) | 15 | 50 |
| Total, serious adverse events | Pazopanib (Treatment Group) | 10 | 55 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37146227 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Temsirolimus (Control Group) vs Pazopanib (Treatment Group): deaths from any cause | Trial comparisons |
| Temsirolimus (Control Group) vs Pazopanib (Treatment Group): serious adverse events | Trial comparisons |
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/NCT01392183
GET https://conductscience.org/api/trials/v1/NCT01392183/flow?page=2