Trial · NCT01876082
PAZOPANIB Efficacy and Tolerance in Desmoids Tumors
NCT01876082, Phase 2, Completed, Institut Bergonié; results first posted 2021-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PAZOPANIB Efficacy and Tolerance in Desmoids Tumors. Trials, record NCT01876082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876082
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PAZOPANIB Efficacy and Tolerance in Desmoids Tumors
- NCT number
- NCT01876082
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Institut Bergonié
- Conditions
- Progressive Desmoids Tumors
- Interventions
- PAZOPANIB treatment, Active Comparator: Vinblastine and Methotrexate
- First posted
- 2013-06-12
- Last updated
- 2025-09-04
- Results first posted
- 2021-03-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Remaining Alive and Progression-free at 6 Months as Per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate). | 6 months | Percentage of patients remaining alive and progression-free at 6 months as per RECIST 1.1 after the day of randomisation. Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. |
| Secondary | Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | 1 year | Best overall response is defined as the best response across all time points (RECIST v1.1). The best overall response is determined once all the data for the participant is known. Each patient has been assigned one of the following categories (RECIST 1.1): complete response (disappearance of all target lesions); partial response (\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); progression (20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and stable disease (nor CR, PR or progression). |
| Secondary | Progression-free Survival | Randomization to disease progression, or death due to any cause, whichever occurs first; until 2 years after the last patient randomized. | Progression-free survival (PFS) defined as the time from randomization to the first documented progression (as per RECIST v1.1) or death (due to any cause), whichever occurs first. Patients alive and progression free were censored at the date of last follow-up, death, or last patient contact. Progression is assessed as per RECIST v1.1. Progression-free survival is estimated as a function of time using Kaplan-Meier method. 1- and 2-year PFS rates were reported. |
| Secondary | Overall Survival | Randomization to disease progression, or death due to any cause, whichever occurs first; until 2 years after the last patient randomized. | Overall survival (OS) defined as the time from randomization to death (due to any cause). Patients alive were censored at the date of last follow-up or last patient contact. Overall survival was estimated as a function of time using Kaplan-Meier method.1- and 2-Year OS rates were 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 | Percentage of Patients Remaining Alive and Progression-free at 6 Months as Per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate). | 6 months | Population evaluable for efficacy included all patients who met eligibility criteria and had received at least one complete cycle or two incomplete cycles of treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | 1 year | Population evaluable for efficacy included all patients who met eligibility criteria and had received at least one complete cycle or two incomplete cycles of treatment. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | Randomization to disease progression, or death due to any cause, whichever occurs first; until 2 years after the last patient randomized. | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | Randomization to disease progression, or death due to any cause, whichever occurs first; until 2 years after the last patient randomized. | Population evaluable for efficacy included all patients who met eligibility criteria and had received at least one complete cycle or two incomplete cycles of treatment. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Remaining Alive and Progression-free at 6 Months as Per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate). | PAZOPANIB | 84.8 | 95% Confidence Interval 71.1 to 93.7 | percentage of participants | |
| Percentage of Patients Remaining Alive and Progression-free at 6 Months as Per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate). | Vinblastine and Methotrexate | 45.0 | 95% Confidence Interval 23.1 to 68.5 | percentage of participants | |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | PAZOPANIB | Complete response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | Vinblastine and Methotrexate | Complete response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | PAZOPANIB | Partial response | 41.3 | 95% Confidence Interval 27.0 to 56.8 | percentage of participants |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | Vinblastine and Methotrexate | Partial response | 30.0 | 95% Confidence Interval 11.9 to 54.3 | percentage of participants |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | PAZOPANIB | Stable disease | 54.4 | 95% Confidence Interval 39.0 to 69.1 | percentage of participants |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | Vinblastine and Methotrexate | Stable disease | 45.0 | 95% Confidence Interval 23.1 to 68.5 | percentage of participants |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | PAZOPANIB | Progression | 4.4 | 95% Confidence Interval 0.5 to 14.8 | percentage of participants |
| Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1. | Vinblastine and Methotrexate | Progression | 20.0 | 95% Confidence Interval 5.7 to 43.7 | percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PAZOPANIB | 48 | |
| Overall Study | STARTED | Vinblastine and Methotrexate | 24 | |
| Overall Study | Safety Population | PAZOPANIB | 48 | |
| Overall Study | Safety Population | Vinblastine and Methotrexate | 22 | |
| Overall Study | COMPLETED | PAZOPANIB | 46 | |
| Overall Study | COMPLETED | Vinblastine and Methotrexate | 20 | |
| Overall Study | NOT COMPLETED | PAZOPANIB | 2 | |
| Overall Study | NOT COMPLETED | Vinblastine and Methotrexate | 4 |
Source ClinicalTrials.gov
Adverse events176
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 | PAZOPANIB | 2 | 48 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Vinblastine and Methotrexate | 5 | 22 | 7 |
| other | Hypothyroidism | Endocrine disorders | PAZOPANIB | 12 | 48 | 13 |
| other | Hypothyroidism | Endocrine disorders | Vinblastine and Methotrexate | 0 | 22 | 0 |
| other | Eye disorders - Other, specify | Endocrine disorders | PAZOPANIB | 7 | 48 | 8 |
| other | Eye disorders - Other, specify | Endocrine disorders | Vinblastine and Methotrexate | 1 | 22 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | PAZOPANIB | 16 | 48 | 29 |
| other | Abdominal pain | Gastrointestinal disorders | Vinblastine and Methotrexate | 6 | 22 | 6 |
| other | Bloating | Gastrointestinal disorders | PAZOPANIB | 4 | 48 | 4 |
| other | Bloating | Gastrointestinal disorders | Vinblastine and Methotrexate | 2 | 22 | 2 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PAZOPANIB | 1 | 48 |
| Total, all-cause mortality | Vinblastine and Methotrexate | 0 | 22 |
| Total, other adverse events | PAZOPANIB | 48 | 48 |
| Total, other adverse events | Vinblastine and Methotrexate | 22 | 22 |
| Total, serious adverse events | PAZOPANIB | 20 | 48 |
| Total, serious adverse events | Vinblastine and Methotrexate | 10 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31331699 | BACKGROUND |
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 |
|---|---|
| PAZOPANIB vs Vinblastine and Methotrexate: deaths from any cause | Trial comparisons |
| PAZOPANIB vs Vinblastine and Methotrexate: 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/NCT01876082
GET https://conductscience.org/api/trials/v1/NCT01876082/events?page=2