Trial · NCT03334409
Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT03334409, Phase 2, Terminated, Academic and Community Cancer Research United; results first posted 2022-03-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery. Trials, record NCT03334409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03334409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Hydrochloride With or Without Ascorbic Acid in Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed by Surgery
- NCT number
- NCT03334409
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
- Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v7, Unresectable Renal Cell Carcinoma
- Interventions
- Ascorbic Acid, Pazopanib Hydrochloride
- First posted
- 2017-11-07
- Last updated
- 2022-03-31
- Results first posted
- 2022-03-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Failure-free Rate | At 40 weeks | Treatment failure is defined as any of the following: radiographic disease progression, off-protocol treatment due to adverse event, initiation of alternative therapy (except metastasectomy post clinical benefit (complete response \[CR\], partial response \[PR\], or stable disease \[SD\] per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 to treatment), and death due to any cause. |
| Secondary | Overall Survival | 26 months | Will be estimated using the method of Kaplan-Meier and be compared using log rank tests. |
| Secondary | Progression Free Survival | 16 Months | Will be estimated using the Kaplan-Meier method. |
| Secondary | Overall Response Rate | 16 Months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan, PET/CT, or MRI: Complete Response (CR), Disappearance of all target lesions and all target lymph nodes must have reduction in short axis to \<1.0 cm; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation; Overall Response (OR) = CR + PR. Will be compared using a Chi-Square test. |
| Secondary | Duration of Time on Pazopanib Hydrochloride | 10 months | Will be described as the median time on treatment by arm. |
| Secondary | Frequency of Adverse Events | 10 Months | Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events and toxicities will be evaluated using all patients who have received any study treatment as well as summarizing those who have been included in the efficacy analyses. The overall adverse event frequencies for grade 3 or higher adverse events, will be compared using Chi-Square tests between the 2 treatment arms. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Failure-free Rate | At 40 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | 26 months | Months | MEDIAN | |
| SECONDARY | Progression Free Survival | 16 Months | Months | MEDIAN | |
| SECONDARY | Overall Response Rate | 16 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Time on Pazopanib Hydrochloride | 10 months | Months | MEDIAN | |
| SECONDARY | Frequency of Adverse Events | 10 Months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Failure-free Rate | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 0 | Participants | ||
| Treatment Failure-free Rate | Arm B (Pazopanib Hydrochloride) | 2 | Participants | ||
| Overall Survival | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 7.8 | Full Range NA to NA | Months | |
| Overall Survival | Arm B (Pazopanib Hydrochloride) | NA | Full Range NA to NA | Months | |
| Progression Free Survival | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 5.7 | Full Range 5.7 to 5.7 | Months | |
| Progression Free Survival | Arm B (Pazopanib Hydrochloride) | 11.8 | Full Range 7.3 to 15.9 | Months | |
| Overall Response Rate | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 0 | Participants | ||
| Overall Response Rate | Arm B (Pazopanib Hydrochloride) | 1 | Participants | ||
| Duration of Time on Pazopanib Hydrochloride | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 5.9 | Full Range 5.9 to 5.9 | Months | |
| Duration of Time on Pazopanib Hydrochloride | Arm B (Pazopanib Hydrochloride) | 9.2 | Full Range 7.3 to 9.2 | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 2 | |
| Overall Study | STARTED | Arm B (Pazopanib Hydrochloride) | 3 | |
| Overall Study | COMPLETED | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 1 | |
| Overall Study | COMPLETED | Arm B (Pazopanib Hydrochloride) | 3 | |
| Overall Study | NOT COMPLETED | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 1 | |
| Overall Study | NOT COMPLETED | Arm B (Pazopanib Hydrochloride) | 0 |
Source ClinicalTrials.gov
Adverse events88
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 | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Pazopanib Hydrochloride) | 1 | 3 | 1 |
| other | Hypothyroidism | Endocrine disorders | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 0 | 1 | 0 |
| other | Hypothyroidism | Endocrine disorders | Arm B (Pazopanib Hydrochloride) | 1 | 3 | 1 |
| other | Dry eye | Eye disorders | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 0 | 1 | 0 |
| other | Dry eye | Eye disorders | Arm B (Pazopanib Hydrochloride) | 1 | 3 | 1 |
| other | Eye disorders - Other, specify | Eye disorders | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 0 | 1 | 0 |
| other | Eye disorders - Other, specify | Eye disorders | Arm B (Pazopanib Hydrochloride) | 1 | 3 | 1 |
| other | Anal fistula | Gastrointestinal disorders | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 0 | 1 | 0 |
| other | Anal fistula | Gastrointestinal disorders | Arm B (Pazopanib Hydrochloride) | 1 | 3 | 1 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 1 | 1 |
| Total, all-cause mortality | Arm B (Pazopanib Hydrochloride) | 0 | 3 |
| Total, other adverse events | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 1 | 1 |
| Total, other adverse events | Arm B (Pazopanib Hydrochloride) | 3 | 3 |
| Total, serious adverse events | Arm A (Pazopanib Hydrochloride, Ascorbic Acid) | 1 | 1 |
| Total, serious adverse events | Arm B (Pazopanib Hydrochloride) | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Pazopanib Hydrochloride, Ascorbic Acid) vs Arm B (Pazopanib Hydrochloride): Treatment Failure-free Rate | Trial comparisons |
| Arm A (Pazopanib Hydrochloride, Ascorbic Acid) vs Arm B (Pazopanib Hydrochloride): Frequency of Adverse Events | Trial comparisons |
| Arm A (Pazopanib Hydrochloride, Ascorbic Acid) vs Arm B (Pazopanib Hydrochloride): Overall Response Rate | Trial comparisons |
| Arm A (Pazopanib Hydrochloride, Ascorbic Acid) vs Arm B (Pazopanib Hydrochloride): deaths from any cause | Trial comparisons |
| Arm A (Pazopanib Hydrochloride, Ascorbic Acid) vs Arm B (Pazopanib Hydrochloride): 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/NCT03334409
GET https://conductscience.org/api/trials/v1/NCT03334409/events?page=2