Trial · NCT00075400

Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer

NCT00075400, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-05-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer. Trials, record NCT00075400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075400

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Trial

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

Title: Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer
NCT number: NCT00075400
Status: Completed
Phases: Phase 2
Enrollment: 26 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Uterine Sarcoma, Uterine Carcinosarcoma
Interventions: imatinib mesylate, laboratory biomarker analysis
First posted: 2004-01-12
Last updated: 2019-07-24
Results first posted: 2015-05-22

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS) > 6 Months	For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Primary	Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Each cycle during treatment and 30 days after treatment ends.	The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
Secondary	Tumor Response	CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Secondary	Overall Survival	From study entry to death or last contact, up to 5 years.	The observed length of life from entry into the study to death or the date of last contact
Secondary	Duration of Progression Free Survival	CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Secondary	Initial Performance Status	Baseline	Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Secondary	Initial Histologic Grade	Baseline	G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Other	PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC	Baseline	Potential associations with clinical or PFS response will be assessed.
Other	AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC	Baseline	Potential associations with clinical or PFS response will be assessed.
Other	p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue	Baseline	Potential associations with clinical or PFS response will be assessed.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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) > 6 Months	For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.	Eligible and treated patients.	percentage of participants	NUMBER
PRIMARY	Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Each cycle during treatment and 30 days after treatment ends.	Eligible and treated patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Tumor Response	CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years	Eligible and treated patients	percentage of participants	NUMBER
SECONDARY	Overall Survival	From study entry to death or last contact, up to 5 years.	Eligible and treated patients	months	MEDIAN
SECONDARY	Duration of Progression Free Survival	CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 years	Eligible and treated patients.	months	MEDIAN
SECONDARY	Initial Performance Status	Baseline	Eligible and treated patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Initial Histologic Grade	Baseline	Eligible and treated patients	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC	Baseline
OTHER_PRE_SPECIFIED	AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC	Baseline
OTHER_PRE_SPECIFIED	p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue	Baseline

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group111

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) > 6 Months	Gleevec		4.3	90% Confidence Interval 0.2 to 19.0	percentage of participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 0	Leukopenia	21		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 1 (CTCAE v 3.0)	Leukopenia	2		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 2 (CTCAE v 3.0)	Leukopenia	0		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 3 (CTCAE v 3.0)	Leukopenia	0		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 4 (CTCAE v 3.0)	Leukopenia	0		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 0	Neutropenia	21		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 1 (CTCAE v 3.0)	Neutropenia	1		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 2 (CTCAE v 3.0)	Neutropenia	1		Participants
Incidence of Adverse Effects as Assessed by CTCAE v 3.0	Grade 3 (CTCAE v 3.0)	Neutropenia	0		Participants

1 to 10 of 111Source ClinicalTrials.gov

See all 111 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gleevec	26
Overall Study	COMPLETED	Gleevec	23
Overall Study	NOT COMPLETED	Gleevec	3

Source ClinicalTrials.gov

Adverse events64

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	Allergic Reaction/Hypersensitivity	Immune system disorders	Gleevec	1	23
other	Rhinitis	Immune system disorders	Gleevec	1	23
other	Tinnitus	Ear and labyrinth disorders	Gleevec	2	23
other	Neutrophils	Blood and lymphatic system disorders	Gleevec	2	23
other	Leukocytes	Blood and lymphatic system disorders	Gleevec	2	23
other	Hemoglobin	Blood and lymphatic system disorders	Gleevec	19	23
other	S/N Arrhythmia: Atrial Tachycardia	Cardiac disorders	Gleevec	1	23
other	Weight Gain	General disorders	Gleevec	1	23
other	Fever	General disorders	Gleevec	1	23
other	Weight Loss	General disorders	Gleevec	1	23

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gleevec
Total, other adverse events	Gleevec	23	23
Total, serious adverse events	Gleevec	7	23

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
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013

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.

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/NCT00075400

GET https://conductscience.org/api/trials/v1/NCT00075400/results?page=2

API reference For AI assistants