Trial · NCT01446809

Pazopanib Hydrochloride Followed by Chemotherapy and Surgery in Treating Patients With Soft Tissue Sarcoma

NCT01446809, Not applicable, Completed, University of Washington; results first posted 2019-04-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pazopanib Hydrochloride Followed by Chemotherapy and Surgery in Treating Patients With Soft Tissue Sarcoma. Trials, record NCT01446809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01446809

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Trial

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

Title: Pazopanib Hydrochloride Followed by Chemotherapy and Surgery in Treating Patients With Soft Tissue Sarcoma
NCT number: NCT01446809
Status: Completed
Phases: Not applicable
Enrollment: 23 participants, actual
Lead sponsor: University of Washington
Conditions: Stage IIA Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
Interventions: Doxorubicin Hydrochloride, External Beam Radiation Therapy, Ifosfamide, Laboratory Biomarker Analysis, Pazopanib Hydrochloride, Pharmacological Study, Placebo, Therapeutic Conventional Surgery
First posted: 2011-10-05
Last updated: 2020-04-13
Results first posted: 2019-04-25

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Change in Maximum SUV of Tumors Measured by FDG-PET Pre- and Post Receipt of Pazopanib Versus Placebo	From baseline to 15 days	Change in maximum SUV (standardized uptake value) of tumors measured by FDG-PET. Comparison conducted using a two-sided Wilcoxon rank sum test.
Primary	Change in Maximum SUV of Tumors Measured by FDG-PET Post Receipt of 2 Courses of Preoperative Chemotherapy	From baseline to 8 weeks	Change in maximum SUV of tumors measured by FDG-PET. Comparison conducted using a two-sided Wilcoxon rank sum test.
Primary	Tumor Response by RECIST Criteria	At 15 days	RECIST measurements will be performed on serial MRIs to evaluate the correlation with FDG-PET. The longest diameter (LD) of the target lesions will be measured and reported as the baseline LD. The baseline LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease.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; Progression (PD), 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
Primary	Tumor Response by RECIST Criteria	At 8 weeks	RECIST measurements will be performed on serial MRIs to evaluate the correlation with FDG-PET. The longest diameter (LD) of the target lesions will be measured and reported as the baseline LD. The baseline LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease.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; Progression (PD), 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
Primary	Pharmacokinetic Profile of Pazopanib	Up to 14 days	Trough plasma pazopanib concentration measured during the 14 day run-in period on days 10 through 14.
Secondary	Change in Levels of VEGF and Soluble VEGFR2 Assessed by ELISA on Plasma and Tumor Extracts	At baseline and after 14 days	Plasma will be collected for measurement of VEGF and soluble VEGFR2 (sVEGFR2) at baseline, after the 14 day Run-in period of pazopanib, after completion of neoadjuvant chemotherapy and approximately every 3 months thereafter until completion of pazopanib maintenance therapy, when indicated. Quantitative enzyme-linked immunosorbent assays (ELISA) for VEGF and sVEGFR2 will be performed on plasma and tumor extracts. Plasma will also be collected for micro RNA at baseline, after the 14 day Run-in period of pazopanib, following neoadjuvant chemotherapy and every 3 months thereafter until completion of pazopanib maintenance therapy, when indicated.
Secondary	Overall Survival	Up to 3 years	Defined as the interval of time from randomization until death from any cause.
Secondary	Number of Participants With Pathologic Response at the Time of Surgery as Measured by % Tumor Viability ( >= 95% Necrosis)	An expected average of 12 weeks	Estimate the amount of viable tumor, and report the percentage of necrosis. Analysis was only completed on a subset of participants.
Secondary	Progression Free Survival	Up to 3 years	Defined as the duration of time from randomization to progressive disease (per RECIST), local recurrence, distant metastatic disease (exclusive of stage IV subjects), or death, whichever occurs first.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Maximum SUV of Tumors Measured by FDG-PET Pre- and Post Receipt of Pazopanib Versus Placebo	From baseline to 15 days		Standardized uptake value-SUV	MEDIAN
PRIMARY	Change in Maximum SUV of Tumors Measured by FDG-PET Post Receipt of 2 Courses of Preoperative Chemotherapy	From baseline to 8 weeks	8 week PET not done on one Pazopanib participant.	SUV	MEDIAN
PRIMARY	Tumor Response by RECIST Criteria	At 15 days	Per 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 LD of target lesions; Progression (PD),20% increase in the sum of the LD of target lesions,or measurable increase in a non-target lesion,or appearance of new lesions.,	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Tumor Response by RECIST Criteria	At 8 weeks	8 week MRI not done on one Placebo patient.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Pharmacokinetic Profile of Pazopanib	Up to 14 days		ng/mL	MEAN
SECONDARY	Change in Levels of VEGF and Soluble VEGFR2 Assessed by ELISA on Plasma and Tumor Extracts	At baseline and after 14 days		percentage of concentration	NUMBER
SECONDARY	Overall Survival	Up to 3 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Pathologic Response at the Time of Surgery as Measured by % Tumor Viability ( >= 95% Necrosis)	An expected average of 12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival	Up to 3 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Spread	Units
Change in Maximum SUV of Tumors Measured by FDG-PET Pre- and Post Receipt of Pazopanib Versus Placebo	Pazopanib		-0.1	Full Range -14.7 to 3.5	Standardized uptake value-SUV
Change in Maximum SUV of Tumors Measured by FDG-PET Pre- and Post Receipt of Pazopanib Versus Placebo	Placebo		-0.1	Full Range -2.2 to 6.0	Standardized uptake value-SUV
Change in Maximum SUV of Tumors Measured by FDG-PET Post Receipt of 2 Courses of Preoperative Chemotherapy	Pazopanib		-1.1	Full Range -32.7 to 5.0	SUV
Change in Maximum SUV of Tumors Measured by FDG-PET Post Receipt of 2 Courses of Preoperative Chemotherapy	Placebo		-4.0	Full Range -11.2 to -0.3	SUV
Tumor Response by RECIST Criteria	Pazopanib	Stable Disease	14		Participants
Tumor Response by RECIST Criteria	Placebo	Stable Disease	6		Participants
Tumor Response by RECIST Criteria	Pazopanib	Progressive Disease	0		Participants
Tumor Response by RECIST Criteria	Placebo	Progressive Disease	1		Participants
Tumor Response by RECIST Criteria	Pazopanib	Stable Disease	11		Participants
Tumor Response by RECIST Criteria	Placebo	Stable Disease	5		Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pazopanib	14
Overall Study	STARTED	Placebo	7
Overall Study	STARTED	Blinded	2
Overall Study	COMPLETED	Pazopanib	14
Overall Study	COMPLETED	Placebo	7
Overall Study	COMPLETED	Blinded	0
Overall Study	NOT COMPLETED	Pazopanib	0
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Blinded	2

Source ClinicalTrials.gov

Adverse events51

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
serious	Hypophosphatemia	Metabolism and nutrition disorders	Pazopanib	1	14
serious	Hypophosphatemia	Metabolism and nutrition disorders	Placebo	0	7
serious	Hypophosphatemia	Metabolism and nutrition disorders	Blinded	0	2
serious	Tumor Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Pazopanib	2	14
serious	Tumor Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo	0	7
serious	Tumor Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Blinded	0	2
serious	Febrile Neutropenia	Blood and lymphatic system disorders	Pazopanib	3	14
serious	Febrile Neutropenia	Blood and lymphatic system disorders	Placebo	4	7
serious	Febrile Neutropenia	Blood and lymphatic system disorders	Blinded	0	2
serious	Alanine Aminotransferase increased	Investigations	Pazopanib	1	14

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pazopanib	2	14
Total, all-cause mortality	Placebo	3	7
Total, all-cause mortality	Blinded	2	2
Total, other adverse events	Pazopanib	0	14
Total, other adverse events	Placebo	0	7
Total, other adverse events	Blinded	0	2
Total, serious adverse events	Pazopanib	9	14
Total, serious adverse events	Placebo	4	7
Total, serious adverse events	Blinded	1	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
P30CA015704	Cancer Center Support Grant	LYNCH, THOMAS JAMES	FRED HUTCHINSON CANCER CENTER	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons3

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

Comparison	Source
Pazopanib vs Placebo: Number of Participants With Pathologic Response at the Time of Surgery as Measured by % Tumor Viability ( >= 95% Necrosis)	Trial comparisons
Arm I (Pazopanib Hydrochloride) vs Arm II (Placebo): Progression Free Survival	Trial comparisons
Pazopanib vs Placebo: Overall Survival	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/NCT01446809

GET https://conductscience.org/api/trials/v1/NCT01446809/results?page=2

API reference For AI assistants