Trial · NCT01532687
Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma
NCT01532687, Phase 2, Completed, OHSU Knight Cancer Institute; results first posted 2021-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma. Trials, record NCT01532687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01532687
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma
- NCT number
- NCT01532687
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
Adult Alveolar Soft Part Sarcoma, Adult Angiosarcoma, Adult Desmoplastic Small Round Cell Tumor, Adult Epithelioid Hemangioendothelioma, Adult Epithelioid Sarcoma, Adult Extraskeletal Myxoid Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Peripheral Nerve Sheath Tumor, Adult Rhabdomyosarcoma, Adult Synovial Sarcoma, Adult Undifferentiated Pleomorphic Sarcoma, Malignant Adult Hemangiopericytoma, Recurrent Adult Soft Tissue Sarcoma, Sarcoma, Stage III Adult Soft Tissue Sarcoma AJCC v7, Stage IV Adult Soft Tissue Sarcoma AJCC v7
- Interventions
- Gemcitabine, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pazopanib, Pazopanib Hydrochloride, Placebo Administration
- First posted
- 2012-02-14
- Last updated
- 2021-09-27
- Results first posted
- 2021-02-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Calculated as the time from randomization to the first documented progression or death, whichever occurs first, or until time of last contact if no progression or death occurred, assessed up to 3 years | Compared using a one-sided Gehan-Wilcoxon test stratified by sarcoma subtype. Kaplan-Meier estimates for each treatment arm will be presented with the estimated hazard ratios and their associated confidence intervals. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the smallest sum on study) with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions. |
| Secondary | Progression-free Survival (PFS) for a Sub-group of Patients Treated With Open-label Pazopanib Hydrochloride Following Administration of Gemcitabine Hydrochloride in the Cross-over Portion of This Study | Calculated as the time from receiving open-labeled pazopanib hydrochloride to the next documented progression or death whichever occurs first, assessed up to 3 years | Participants who progress during treatment and are found to be part of the gemcitabine+placebo arm after unblinding are eligible to receive open-label pazopanib with gemcitabine. This is the crossover population. Statistical analysis is exploratory and requires sufficient crossover participants to assess Kaplan-Meier estimated hazard ratio and associated 95% confidence interval. This represents the participants second progression. In both cases progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 as at least a 20% increase in the sum of the longest diameters of target lesions with an absolute increase of at least 5 mm (target lesions), or measurable increase in non-target lesions (unequivocal progression), or appearance of one or more new lesions. First progression uses the smallest sum on study as a reference; progression for the crossover population uses first progression measurements as the reference. |
| Secondary | Percentage of Participants Achieving Best Overall Objective Response (CR+PR) | Best overall objective response recorded from the start of treatment until disease progression/recurrence assessed up to 3 years | Response is evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where RECIST combines assessments for target, non-target and presence of new lesions. Best Overall Objective Response is the sum of all CR+PR divided by all randomized participants, where the strongest recorded response is used for the evaluation (CR\>PR\>SD\>PD). Objective response (CR+PR) requires at least a 30% decrease in the sum of the largest diameter target lesions (with respective to the baseline sum); disappearance of all or persistence of one or more non-target lesions, maintenance of tumor marker levels above normal limits, and no new lesions. Estimated odds ratio of best overall objective response are reported with 95% confidence interval for the two histologic sarcoma subgroups (liposarcoma vs all other eligible soft tissue sarcoma subtypes). One-sided proportions test is used to determine whether best overall objective response is greater for the gemcitabine plus pazopanib group. |
| Secondary | Overall Survival | From randomization to death due to any cause, or until last patient contact if the patient did not die, assessed up to 3 years | Two treatment arms will be compared using a one-sided log-rank test stratified by sarcoma subtype and study site. Kaplan-Meier estimates and the survival curves for each treatment arm will be presented with the estimated hazard ratios and their associated confidence interval. |
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 | Progression-free Survival (PFS) | Calculated as the time from randomization to the first documented progression or death, whichever occurs first, or until time of last contact if no progression or death occurred, assessed up to 3 years | All randomized participants | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) for a Sub-group of Patients Treated With Open-label Pazopanib Hydrochloride Following Administration of Gemcitabine Hydrochloride in the Cross-over Portion of This Study | Calculated as the time from receiving open-labeled pazopanib hydrochloride to the next documented progression or death whichever occurs first, assessed up to 3 years | Participants randomized to the gemcitabine + placebo arm who progressed and elected to receive gemcitibine + open-label pazopanib | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Best Overall Objective Response (CR+PR) | Best overall objective response recorded from the start of treatment until disease progression/recurrence assessed up to 3 years | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From randomization to death due to any cause, or until last patient contact if the patient did not die, assessed up to 3 years | All randomized participants | months | MEDIAN |
Source ClinicalTrials.gov
Results by group19
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) | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | All randomized | 4.5 | 95% Confidence Interval 3.0 to 8.5 | months |
| Progression-free Survival (PFS) | Gemcitabine Hydrochloride Plus Placebo | All randomized | 1.6 | 95% Confidence Interval 1.4 to 4.3 | months |
| Progression-free Survival (PFS) | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | Liposarcoma | 8.9 | 95% Confidence Interval 4.3 to NA | months |
| Progression-free Survival (PFS) | Gemcitabine Hydrochloride Plus Placebo | Liposarcoma | 1.5 | 95% Confidence Interval 1.0 to NA | months |
| Progression-free Survival (PFS) | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | Other Sarcoma | 4.4 | 95% Confidence Interval 3.0 to 8.8 | months |
| Progression-free Survival (PFS) | Gemcitabine Hydrochloride Plus Placebo | Other Sarcoma | 2.2 | 95% Confidence Interval 1.4 to 4.6 | months |
Progression-free Survival (PFS) for a Sub-group of Patients Treated With Open-label Pazopanib Hydrochloride Following Administration of Gemcitabine Hydrochloride in the Cross-over Portion of This Study | Crossover From Gemcitabine + Placebo to Gemcitabine + Open-label Pazopanib | 3.0 | 95% Confidence Interval 1.3 to NA | months | |
| Percentage of Participants Achieving Best Overall Objective Response (CR+PR) | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | All randomized participants | 6.9 | 95% Confidence Interval 0.9 to 22.8 | percentage of participants |
| Percentage of Participants Achieving Best Overall Objective Response (CR+PR) | Gemcitabine Hydrochloride Plus Placebo | All randomized participants | 8.0 | 95% Confidence Interval 1.0 to 26.0 | percentage of participants |
| Percentage of Participants Achieving Best Overall Objective Response (CR+PR) | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | Liposarcoma participants | 22.2 | 95% Confidence Interval 2.8 to 60 | percentage of participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 29 | |
| Overall Study | STARTED | Gemcitabine Hydrochloride Plus Placebo | 25 | |
| Overall Study | Crossover to Open-label Pazopanib | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 0 | |
| Overall Study | Crossover to Open-label Pazopanib | Gemcitabine Hydrochloride Plus Placebo | 14 | |
| Overall Study | COMPLETED | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 15 | |
| Overall Study | COMPLETED | Gemcitabine Hydrochloride Plus Placebo | 23 | |
| Overall Study | NOT COMPLETED | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 14 | |
| Overall Study | NOT COMPLETED | Gemcitabine Hydrochloride Plus Placebo | 2 |
Source ClinicalTrials.gov
Adverse events168
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 pain | Gastrointestinal disorders | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 0 | 29 | |
| other | Abdominal pain | Gastrointestinal disorders | Gemcitabine Hydrochloride Plus Placebo | 1 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib | 2 | 14 | |
| other | Alanine aminotransferase increased | Investigations | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 3 | 29 | |
| other | Alanine aminotransferase increased | Investigations | Gemcitabine Hydrochloride Plus Placebo | 1 | 25 | |
| other | Alanine aminotransferase increased | Investigations | Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib | 0 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 2 | 29 | |
| other | Anemia | Blood and lymphatic system disorders | Gemcitabine Hydrochloride Plus Placebo | 3 | 25 | |
| other | Anemia | Blood and lymphatic system disorders | Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib | 0 | 14 | |
| other | Aspartate aminotransferase increased | Investigations | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 2 | 29 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 23 | 29 |
| Total, all-cause mortality | Gemcitabine Hydrochloride Plus Placebo | 10 | 11 |
| Total, all-cause mortality | Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib | 11 | 14 |
| Total, other adverse events | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 25 | 29 |
| Total, other adverse events | Gemcitabine Hydrochloride Plus Placebo | 14 | 25 |
| Total, other adverse events | Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib | 9 | 14 |
| Total, serious adverse events | Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 8 | 29 |
| Total, serious adverse events | Gemcitabine Hydrochloride Plus Placebo | 6 | 25 |
| Total, serious adverse events | Crossover From Gemcitabine Plus Placebo to Gemcitabine Plus Open-label Pazopanib | 5 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31401903 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P30CA069533 | OHSU Knight Cancer Institute | KUMMAR, SHIVAANI | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1997 to 2025 |
Source 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/NCT01532687
GET https://conductscience.org/api/trials/v1/NCT01532687/events?page=2