Trial · NCT01418001
Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)
NCT01418001, Phase 1, Phase 2, Terminated, Memorial Sloan Kettering Cancer Center; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS). Trials, record NCT01418001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01418001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS)
- NCT number
- NCT01418001
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Sarcoma, Leiomyosarcoma, Malignant Peripheral Nerve Sheath Tumor, Malignant Fibrous, Histiocytoma/Undifferentiated Pleomorphic Sarcoma
- Interventions
- Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination
- First posted
- 2011-08-16
- Last updated
- 2018-01-11
- Results first posted
- 2016-02-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Objective Response | Every 6 weeks up to 2 years | Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Pathologic Response | 2 years | will be assessed by both MRI and by pathologic review after surgery. An estimate of each response rate and the 95% CI will be provided |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Objective Response | Every 6 weeks up to 2 years | participants | NUMBER | |
| SECONDARY | Pathologic Response | 2 years | No data is available because data was not collected due to lack of accrual. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Objective Response | Level 1: Pazopanib 400 mg QD | Complete Response (CR) | 3 | participants | |
| Overall Objective Response | Level 1: Pazopanib 400 mg QD | Stable Disease (SD) | 2 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib 400 mg QD | 5 | |
| Overall Study | COMPLETED | Pazopanib 400 mg QD | 5 | |
| Overall Study | NOT COMPLETED | Pazopanib 400 mg QD | 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 | Alanine aminotransferase increased | Blood and lymphatic system disorders | Level 1: Pazopanib 400 mg QD | 2 | 5 | |
| other | Anemia | Blood and lymphatic system disorders | Level 1: Pazopanib 400 mg QD | 4 | 5 | |
| other | Aspartate aminotransferase increased | Blood and lymphatic system disorders | Level 1: Pazopanib 400 mg QD | 1 | 5 | |
| other | Diarrhea | Gastrointestinal disorders | Level 1: Pazopanib 400 mg QD | 1 | 5 | |
| other | Fatigue | General disorders | Level 1: Pazopanib 400 mg QD | 2 | 5 | |
| other | Hoarseness | General disorders | Level 1: Pazopanib 400 mg QD | 1 | 5 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Level 1: Pazopanib 400 mg QD | 2 | 5 | |
| other | Hypertension | Cardiac disorders | Level 1: Pazopanib 400 mg QD | 1 | 5 | |
| other | Hypertriglyceridemia | Metabolism and nutrition disorders | Level 1: Pazopanib 400 mg QD | 2 | 5 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Level 1: Pazopanib 400 mg QD | 2 | 5 |
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 | Level 1: Pazopanib 400 mg QD | ||
| Total, other adverse events | Level 1: Pazopanib 400 mg QD | 5 | 5 |
| Total, serious adverse events | Level 1: Pazopanib 400 mg QD | 3 | 5 |
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/NCT01418001
GET https://conductscience.org/api/trials/v1/NCT01418001/registered