Trial · NCT01692496
Activity and Tolerability of Pazopanib in Advanced and/or Metastatic Liposarcoma. A Phase II Clinical Trial
NCT01692496, Phase 2, Completed, Grupo Espanol de Investigacion en Sarcomas; results first posted 2020-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Activity and Tolerability of Pazopanib in Advanced and/or Metastatic Liposarcoma. A Phase II Clinical Trial. Trials, record NCT01692496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01692496
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Activity and Tolerability of Pazopanib in Advanced and/or Metastatic Liposarcoma. A Phase II Clinical Trial
- NCT number
- NCT01692496
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Grupo Espanol de Investigacion en Sarcomas
- Conditions
- Advanced and / or Metastatic Liposarcoma
- Interventions
- Pazopanib
- First posted
- 2012-09-25
- Last updated
- 2020-07-23
- Other registries' IDs
- eudract:2012-002745-38
- Results first posted
- 2020-07-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Assessed 12 Weeks After Start of Treatment | 12 weeks after start of treatment | The primary objective of this study is to evaluate the activity of Pazopanib in patients with advanced and/or metastatic liposarcoma by means of progression-free survival (PFS) assessed 12 weeks after start of treatment. (According the RECIST criteria 1.1 and central radiology review). Progression was defined according to RECIST criteria 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Overall Progression Free Survival (Median PFS) | Imaging studies repeated every 6 weeks for the first 12 weeks and every 8 weeks up to 36 months. | Overall progression free survival will be computed from the date of start of treatment to the first documented date of progression or the date of death, whatever the cause. Patients alive and free from progression at the time of the analysis will be censored at the date of last follow-up. |
| Secondary | Percentage of Patients With Objective Tumor Response (OR) | 6 weeks and 12 weeks | Objective tumor response, measured according to the RECIST 1.1 criteria (central reviewing) at 6 and 12 weeks. Response criteria are essentially based on a set of measurable lesions identified at baseline as target lesions, and followed until disease progression. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Overall Survival (OS) | Every 12 weeks from disease progression up to 36 months. | It will be computed from the date of start of treatment to the date of death, whatever the cause. Patients alive or lost for follow-up at the time of the analysis will be censored at the date of last follow-up. |
| Secondary | Clinical Benefit Rate | Imaging studies required to investigate known disease should be repeated every 6 weeks for the first 12 weeks and every 8 weeks up to 36 months. | Patients who achieve complete response (CR), partial response (PR), or stable disease (SD) for 6 months or more and an improvement of symptoms will be considered as having derived clinical benefit. |
| Secondary | Growth Modulation Index (GMI) | Imaging studies required to investigate known disease should be repeated every 6 weeks for the first 12 weeks and every 8 weeks up to 36 months. At patient progression confirmed by means RECIST criteria V 1.1 | GMI is the ratio between time to progression (TTP) with pazopanib (TTPp) divided by the TTPp-1 with the previous line of therapy. GMI index values higher than 1 indicate that Pazopanib treatment has an increased time to progression when compared to previous line of treatment. GMI index values lower than 1 indicate that Pazopanib treatment has a reduced time to progression when compared to previous line of treatment. Higher GMI values are associated to a better outcome. |
| Secondary | Safety Profile (According CTCAE, Version 4.0) | Every week during the first month, week 6, week 9, week 12, every 4 weeks until end of treatment and at the end of treatment visit (28 days after the end of treatment), up to 36 months | The safety and tolerability of Pazopanib will be determined by means of type, incidence, severity, timing, seriousness, and relatedness; of reported adverse events (AEs), physical examinations, and laboratory tests. Toxicity will be graded and tabulated by the NCI-CTCAE v 4.0. |
Source ClinicalTrials.gov
Outcomes7
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) Assessed 12 Weeks After Start of Treatment | 12 weeks after start of treatment | Per protocol population | percentage of participants | NUMBER |
| SECONDARY | Overall Progression Free Survival (Median PFS) | Imaging studies repeated every 6 weeks for the first 12 weeks and every 8 weeks up to 36 months. | Per protocol | Weeks | MEDIAN |
| SECONDARY | Percentage of Patients With Objective Tumor Response (OR) | 6 weeks and 12 weeks | Per protocol (PP) | Percentage of patients | NUMBER |
| SECONDARY | Overall Survival (OS) | Every 12 weeks from disease progression up to 36 months. | Per protocol | Weeks | MEDIAN |
| SECONDARY | Clinical Benefit Rate | Imaging studies required to investigate known disease should be repeated every 6 weeks for the first 12 weeks and every 8 weeks up to 36 months. | Per population | Percentage of patients | NUMBER |
| SECONDARY | Growth Modulation Index (GMI) | Imaging studies required to investigate known disease should be repeated every 6 weeks for the first 12 weeks and every 8 weeks up to 36 months. At patient progression confirmed by means RECIST criteria V 1.1 | Per protocol with TTP and TTPp registered | Arbitrary units | MEDIAN |
| SECONDARY | Safety Profile (According CTCAE, Version 4.0) | Every week during the first month, week 6, week 9, week 12, every 4 weeks until end of treatment and at the end of treatment visit (28 days after the end of treatment), up to 36 months | Intention to treat | Patients | NUMBER |
Source ClinicalTrials.gov
Results by group31
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) Assessed 12 Weeks After Start of Treatment | Pazopanib | Cohort A | 54.1 | 95% Confidence Interval 38 to 70.2 | percentage of participants |
| Progression-free Survival (PFS) Assessed 12 Weeks After Start of Treatment | Pazopanib | Cohort B | 46.2 | 95% Confidence Interval 19.1 to 73.3 | percentage of participants |
| Overall Progression Free Survival (Median PFS) | Pazopanib | Pazopanib | 12.14 | 95% Confidence Interval 7.75 to 16.53 | Weeks |
| Overall Progression Free Survival (Median PFS) | Pazopanib | Cohort A | 15 | 95% Confidence Interval 8.19 to 21.8 | Weeks |
| Overall Progression Free Survival (Median PFS) | Pazopanib | Cohort B | 10.29 | 95% Confidence Interval 5.09 to 15.49 | Weeks |
| Percentage of Patients With Objective Tumor Response (OR) | Pazopanib | 6 weeks OR (PP population) | 8 | 95% Confidence Interval 0.5 to 15.5 | Percentage of patients |
| Percentage of Patients With Objective Tumor Response (OR) | Pazopanib | 12 weeks OR (PP population) | 4 | 95% Confidence Interval 1.4 to 9.4 | Percentage of patients |
| Overall Survival (OS) | Pazopanib | Pazopanib | 70.43 | 95% Confidence Interval 44.92 to 95.94 | Weeks |
| Overall Survival (OS) | Pazopanib | Cohort A | 70.43 | 95% Confidence Interval 42.69 to 98.1 | Weeks |
| Overall Survival (OS) | Pazopanib | Cohort B | 71.29 | 95% Confidence Interval 31.21 to 111.36 | Weeks |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib | 52 | |
| Overall Study | 3 Weeks Pazopanib (Per Protocol PP) | Pazopanib | 50 | |
| Overall Study | COMPLETED | Pazopanib | 52 | |
| Overall Study | NOT COMPLETED | Pazopanib | 0 |
Source ClinicalTrials.gov
Adverse events19
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 | Adverse Events | General disorders | Pazopanib | 52 | 52 | |
| serious | Abscess of tumor mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Pazopanib | 1 | 52 | 1 |
| serious | ALT increased | Blood and lymphatic system disorders | Pazopanib | 2 | 52 | 3 |
| serious | Anemia | Blood and lymphatic system disorders | Pazopanib | 1 | 52 | 1 |
| serious | Ascites | General disorders | Pazopanib | 1 | 52 | 1 |
| serious | General status deterioration | General disorders | Pazopanib | 1 | 52 | 1 |
| serious | Gastrointestinal bleeding | Gastrointestinal disorders | Pazopanib | 1 | 52 | 1 |
| serious | Cardiac dysrhythmia | Cardiac disorders | Pazopanib | 1 | 52 | 1 |
| serious | Febrile neutropenia | Immune system disorders | Pazopanib | 1 | 52 | 1 |
| serious | Fatigue | General disorders | Pazopanib | 1 | 52 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib | 35 | 52 |
| Total, other adverse events | Pazopanib | 52 | 52 |
| Total, serious adverse events | Pazopanib | 14 | 52 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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/NCT01692496
GET https://conductscience.org/api/trials/v1/NCT01692496/results?page=2