Trial · NCT01593748

A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma

NCT01593748, Phase 2, Completed, Medical University of South Carolina; results first posted 2020-04-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma. Trials, record NCT01593748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01593748

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
NCT number: NCT01593748
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: Medical University of South Carolina
Conditions: Sarcoma
Interventions: Gemcitabine and Pazopanib, Gemcitabine and Docetaxel
First posted: 2012-05-08
Last updated: 2020-04-06
Results first posted: 2020-04-06

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Average Number of Months of Progression-free Survival	minimum of 18 months	To estimate the PFS of the combination of G+P or G+T in patients with metastatic and/or locally advanced or recurrent STS. Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Primary	Rate of Participants With Grade 3 or Higher Toxicity	30 days post end of treatment	Toxicity is graded according to the CTCAE v 4.
Secondary	Hazard Ratio	minimum of 18 months	Hazard ratio is defined as the rate of survival in the experimental group versus the standard of care group. A hazard ratio of greater than one or less than one means that survival was better in one of the groups.
Secondary	Average Score of Quality of Life	Baseline, Cycle 2, Cycle 6 and End of Treatment	To estimate the quality of life of patient with metastatic an/or locally advanced recurrent STS using the Quality of Life Questionnaire (QLQ-C30). The QLQ-C30 is scored on a scale from 0-100 with "0" indicating "never" and "100" indicating "always" in regard the the participants' experience of fatigue, nausea/vomiting, pain, disponae, insomnia, appetite loss, constipation, diarrhea, financial concerns at 4 time points through the study.
Secondary	Response Rate	minimum of 18 months	Response rate is defined as follows: 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. 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

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Average Number of Months of Progression-free Survival	minimum of 18 months	months	MEDIAN
PRIMARY	Rate of Participants With Grade 3 or Higher Toxicity	30 days post end of treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hazard Ratio	minimum of 18 months	hazard ratio	NUMBER
SECONDARY	Average Score of Quality of Life	Baseline, Cycle 2, Cycle 6 and End of Treatment	score on a scale	MEAN
SECONDARY	Response Rate	minimum of 18 months	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group86

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Average Number of Months of Progression-free Survival	Experimental		4.1	95% Confidence Interval 2.4 to 8.6	months
Average Number of Months of Progression-free Survival	Standard of Care		4.1	95% Confidence Interval 2.7 to 11.4	months
Rate of Participants With Grade 3 or Higher Toxicity	Experimental		39		Participants
Rate of Participants With Grade 3 or Higher Toxicity	Standard of Care		39		Participants
Hazard Ratio	Experimental		1.2	95% Confidence Interval 0.7 to 2.0	hazard ratio
Hazard Ratio	Standard of Care		NA	95% Confidence Interval NA to NA	hazard ratio
Average Score of Quality of Life	Experimental	Fatigue at baseline	61.79	Standard Deviation 27.89	score on a scale
Average Score of Quality of Life	Standard of Care	Fatigue at baseline	67.12	Standard Deviation 23.44	score on a scale
Average Score of Quality of Life	Experimental	Nausea/Vommiting at baseline	91.06	Standard Deviation 14.48	score on a scale
Average Score of Quality of Life	Standard of Care	Nausea/Vommiting at baseline	90.99	Standard Deviation 16.94	score on a scale

1 to 10 of 86Source ClinicalTrials.gov

See all 86 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental	45
Overall Study	STARTED	Standard of Care	45
Overall Study	COMPLETED	Experimental	45
Overall Study	COMPLETED	Standard of Care	45
Overall Study	NOT COMPLETED	Experimental	0
Overall Study	NOT COMPLETED	Standard of Care	0

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
other	Fatigue	General disorders	Experimental	34	45
other	Fatigue	General disorders	Standard of Care	28	45
other	Platelet Count Decreased	Investigations	Experimental	34	45
other	Platelet Count Decreased	Investigations	Standard of Care	33	45
other	Nausea	Gastrointestinal disorders	Experimental	31	45
other	Nausea	Gastrointestinal disorders	Standard of Care	18	45
other	Anemia	Blood and lymphatic system disorders	Experimental	27	45
other	Anemia	Blood and lymphatic system disorders	Standard of Care	32	45
other	Constipation	Gastrointestinal disorders	Experimental	13	45
other	Constipation	Gastrointestinal disorders	Standard of Care	19	45

1 to 10 of 168Source ClinicalTrials.gov

See all 168 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental	32	45
Total, all-cause mortality	Standard of Care	30	45
Total, other adverse events	Experimental	45	45
Total, other adverse events	Standard of Care	45	45
Total, serious adverse events	Experimental	28	45
Total, serious adverse events	Standard of Care	31	45

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11904577	BACKGROUND	PubMed
15530457	BACKGROUND	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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Experimental vs Standard of Care: Rate of Participants With Grade 3 or Higher Toxicity	Trial comparisons
Experimental vs Standard of Care: deaths from any cause	Trial comparisons
Experimental vs Standard of Care: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01593748

GET https://conductscience.org/api/trials/v1/NCT01593748/results?page=2

API reference For AI assistants