Trial · NCT00454363
Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer
NCT00454363, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib Hydrochloride in Treating Patients With Advanced Neuroendocrine Cancer. Trials, record NCT00454363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00454363
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 Neuroendocrine Cancer
- NCT number
- NCT00454363
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Gastrin-Producing Neuroendocrine Tumor, Lung Carcinoid Tumor, Metastatic Digestive System Neuroendocrine Tumor G1, Multiple Endocrine Neoplasia Type 1, Pancreatic Glucagonoma, Pancreatic Insulinoma, Pancreatic Polypeptide Tumor, Recurrent Digestive System Neuroendocrine Tumor G1, Recurrent Pancreatic Neuroendocrine Carcinoma, Regional Digestive System Neuroendocrine Tumor G1, Somatostatin-Producing Neuroendocrine Tumor
- Interventions
- Laboratory Biomarker Analysis, Pazopanib Hydrochloride, Pharmacological Study
- First posted
- 2007-03-30
- Last updated
- 2020-04-03
- Results first posted
- 2015-04-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 18 months | RECIST Criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance 1/\> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. |
| Secondary | Percent Change in Tumor Blood Flow Assessed by Functional CT | Baseline and week 12 | Explore the effect on tumor blood flow as determined by functional CT of GW786034 (Pazopanib) 800 mg orally once daily on both arms, carcinoid and pNET. |
| Other | Progression Free Survival (PFS) | Baseline to 18 months. | PFS is defined as the duration of time from start of treatment to time of progression or death. |
| Other | Plasma Trough Level of GW786034 | assessed at Baseline and day 28, day 28 reported |
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 | Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 18 months | RECIST best protocol response by intention to treat. Four participants were not evaluable for response. | participants | NUMBER |
| SECONDARY | Percent Change in Tumor Blood Flow Assessed by Functional CT | Baseline and week 12 | Data were not collected from any participant in the Pazopanib + Carcinoid Arm Group | percentage of change in tumor blood flow | MEDIAN |
| OTHER_PRE_SPECIFIED | Progression Free Survival (PFS) | Baseline to 18 months. | Analysis calculated according to intent to treat. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Plasma Trough Level of GW786034 | assessed at Baseline and day 28, day 28 reported | Plasma trough level in blood was below the level of detection. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + Carcinoid | PR | 0 | participants | |
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + pNET | PR | 6 | participants | |
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + Carcinoid | SD | 14 | participants | |
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + pNET | SD | 21 | participants | |
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + Carcinoid | PD | 3 | participants | |
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + pNET | PD | 3 | participants | |
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + Carcinoid | Not Evaluable | 3 | participants | |
| Objective Response Rate (Complete and Partial Response) for Each Cohort Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Pazopanib + pNET | Not Evaluable | 1 | participants | |
| Percent Change in Tumor Blood Flow Assessed by Functional CT | Pazopanib + pNET | 139 | Full Range -56 to 154 | percentage of change in tumor blood flow | |
| Progression Free Survival (PFS) | Pazopanib + Carcinoid | 12 | 95% Confidence Interval 3.4 to 20.6 | months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib + Carcinoid | 20 | |
| Overall Study | STARTED | Pazopanib + pNET | 31 | |
| Overall Study | COMPLETED | Pazopanib + Carcinoid | 15 | |
| Overall Study | COMPLETED | Pazopanib + pNET | 29 | |
| Overall Study | NOT COMPLETED | Pazopanib + Carcinoid | 5 | |
| Overall Study | NOT COMPLETED | Pazopanib + pNET | 2 |
Source ClinicalTrials.gov
Adverse events135
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 distension | Gastrointestinal disorders | Pazopanib | 2 | 51 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Pazopanib | 36 | 51 | 78 |
| other | Acidosis | Metabolism and nutrition disorders | Pazopanib | 2 | 51 | 4 |
| other | Activated partial thromboplastin time prolonged | Blood and lymphatic system disorders | Pazopanib | 5 | 51 | 10 |
| other | Agitation | Psychiatric disorders | Pazopanib | 1 | 51 | 1 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Pazopanib | 19 | 51 | 58 |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | Pazopanib | 9 | 51 | 28 |
| other | Allergic rhinitis | Immune system disorders | Pazopanib | 3 | 51 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pazopanib | 3 | 51 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Pazopanib | 23 | 51 | 45 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib | ||
| Total, other adverse events | Pazopanib | 51 | 51 |
| Total, serious adverse events | Pazopanib | 16 | 51 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25956795 | DERIVED |
Source PubMed
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA062490 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
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/NCT00454363
GET https://conductscience.org/api/trials/v1/NCT00454363/events?page=2