Trial · NCT01340794
Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma
NCT01340794, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-07-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma. Trials, record NCT01340794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01340794
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma
- NCT number
- NCT01340794
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Extra-Adrenal Paraganglioma, Metastatic Adrenal Gland Pheochromocytoma, Paraganglioma, Recurrent Adrenal Gland Pheochromocytoma
- Interventions
- Laboratory Biomarker Analysis, Pazopanib Hydrochloride
- First posted
- 2011-04-25
- Last updated
- 2017-09-21
- Results first posted
- 2016-07-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1 | Up to 5 years | Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1) Ninety-five percent confidence intervals for the true response proportion was calculated using the exact binomial test. Complete Response (CR): All of the following must be true: 1. Disappearance of all target and non-target lesions. 2. Each lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking baseline measures as reference. Overall Response (OR) was calculated by summing the number of patients with a CR or PR. |
| Secondary | Duration of Tumor Response | Up to 5 years | Defined for all patients whose tumor met the criteria of CR or PR (using the RECIST criteria) as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. |
| Secondary | Overall Survival Time | The time from registration to death due to any cause, assessed up to 5 years | Overall survival time is defined as the time from registration to death due to any cause and will be estimated using the Kaplan-Meier method. |
| Secondary | Progression-free Survival Time | The time from registration to documentation of disease progression or death, whichever occurs first, assessed up to 5 years | Progression-free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Progression-free survival time will be estimated using the Kaplan-Meier method. |
| Secondary | Time to Treatment Failure | Up to 5 years from registration | The time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1 | Up to 5 years | One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable | percentage of participants | NUMBER |
| SECONDARY | Duration of Tumor Response | Up to 5 years | One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. None of the 4 patients that initiated treatment with a run-in responded | ||
| SECONDARY | Overall Survival Time | The time from registration to death due to any cause, assessed up to 5 years | One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable | months | MEDIAN |
| SECONDARY | Progression-free Survival Time | The time from registration to documentation of disease progression or death, whichever occurs first, assessed up to 5 years | One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | Up to 5 years from registration | One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable. | 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 |
|---|---|---|---|---|---|
| Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1 | Treatment: Pazopanib Run-in | 0 | 95% Confidence Interval 0 to 60 | percentage of participants | |
| Overall Survival Time | Treatment: Pazopanib With Run-in | 14.8 | 95% Confidence Interval 7.6 to 26.3 | months | |
| Progression-free Survival Time | Treatment: Pazopanib Run-in | 6.5 | 95% Confidence Interval 2.1 to 26.3 | months | |
| Time to Treatment Failure | Treatment: Pazopanib Run-in | 2.4 | 95% Confidence Interval 0.8 to 5.7 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment: Pazopanib With no Run-in | 2 | |
| Overall Study | STARTED | Treatment: Pazopanib Run-in | 5 | |
| Overall Study | COMPLETED | Treatment: Pazopanib With no Run-in | 2 | |
| Overall Study | COMPLETED | Treatment: Pazopanib Run-in | 4 | |
| Overall Study | NOT COMPLETED | Treatment: Pazopanib With no Run-in | 0 | |
| Overall Study | NOT COMPLETED | Treatment: Pazopanib Run-in | 1 |
Source ClinicalTrials.gov
Adverse events100
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 | Treatment: Pazopanib Without Run-in | 1 | 2 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Treatment: Pazopanib With Run-in | 0 | 4 | 0 |
| other | Hypothyroidism | Endocrine disorders | Treatment: Pazopanib Without Run-in | 1 | 2 | 27 |
| other | Hypothyroidism | Endocrine disorders | Treatment: Pazopanib With Run-in | 1 | 4 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment: Pazopanib Without Run-in | 1 | 2 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment: Pazopanib With Run-in | 0 | 4 | 0 |
| other | Anal pain | Gastrointestinal disorders | Treatment: Pazopanib Without Run-in | 1 | 2 | 1 |
| other | Anal pain | Gastrointestinal disorders | Treatment: Pazopanib With Run-in | 0 | 4 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Treatment: Pazopanib Without Run-in | 1 | 2 | 28 |
| other | Diarrhea | Gastrointestinal disorders | Treatment: Pazopanib With Run-in | 2 | 4 | 2 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment: Pazopanib Without Run-in | ||
| Total, all-cause mortality | Treatment: Pazopanib With Run-in | ||
| Total, other adverse events | Treatment: Pazopanib Without Run-in | 2 | 2 |
| Total, other adverse events | Treatment: Pazopanib With Run-in | 4 | 4 |
| Total, serious adverse events | Treatment: Pazopanib Without Run-in | 2 | 2 |
| Total, serious adverse events | Treatment: Pazopanib With Run-in | 1 | 4 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Treatment: Pazopanib Without Run-in vs Treatment: Pazopanib With Run-in: serious adverse events |
Source 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/NCT01340794
GET https://conductscience.org/api/trials/v1/NCT01340794/events?page=2