Trial · NCT00490451

A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma

NCT00490451, Phase 2, Completed, Eli Lilly and Company; results first posted 2018-05-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma. Trials, record NCT00490451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00490451

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Trial

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

Title: A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma
NCT number: NCT00490451
Status: Completed
Phases: Phase 2
Enrollment: 101 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Sarcoma, Soft Tissue
Interventions: LY573636-sodium
First posted: 2007-06-22
Last updated: 2019-09-18
Results first posted: 2018-05-02

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Progression-Free Survival	First treatment dose to measured progressive disease or death from any cause up to 15.57 months	Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Secondary	Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	First treatment dose to measured progressive disease or death due to any cause up to 15.57 months	Objective response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Secondary	Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)	First treatment dose to measured progressive disease or death due to any cause up to 15.57 months	Clinical Benefit Rate = (CR + PR + SD)/N as classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0), where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY573636	Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle)
Secondary	Overall Survival Time	First treatment dose to death due to any cause up to 26.51 months	Defined as the time from date of first dose to the date of death due to any cause.
Secondary	Duration of Overall Objective Response	Time of response to progressive disease or death up to 15.57 months	The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression of disease or death due to any cause. CR or PR is classified according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.0). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.
Secondary	Duration of Stable Disease (SD)	Time from documented SD or better to first date of progressive disease up to 15.57 months	Duration of SD is defined from date of documented SD or better to first date of progression of disease (PD) (assessed every other cycle during study therapy, or every 2 months during post-therapy until PD). SD is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Secondary	Number of Participants With Adverse Events (Safety)	First treatment dose up to 26.51 months	Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival	First treatment dose to measured progressive disease or death from any cause up to 15.57 months	All enrolled participants who received at least 1 dose of study drug.	months	MEDIAN
SECONDARY	Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	First treatment dose to measured progressive disease or death due to any cause up to 15.57 months	All enrolled participants who received at least 1 dose of study drug.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)	First treatment dose to measured progressive disease or death due to any cause up to 15.57 months	All enrolled participants who received at least 1 dose of study drug.	percentage of participants	NUMBER
SECONDARY	Pharmacokinetics: Maximum Concentration (Cmax) of LY573636	Predose up to 2 hours postdose in Cycles 1 and 2 (21- or 28-day cycle)	Participants who received study drug and had pharmacokinetic (PK) data at the specified time points.	micrograms/milliliter (µg/mL)	GEOMETRIC_MEAN
SECONDARY	Overall Survival Time	First treatment dose to death due to any cause up to 26.51 months	All enrolled participants who received at least 1 dose of study drug.	months	MEDIAN
SECONDARY	Duration of Overall Objective Response	Time of response to progressive disease or death up to 15.57 months	Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
SECONDARY	Duration of Stable Disease (SD)	Time from documented SD or better to first date of progressive disease up to 15.57 months	All enrolled participants who received at least 1 dose of study drug and had a best overall response of stable disease or better.	months	MEDIAN
SECONDARY	Number of Participants With Adverse Events (Safety)	First treatment dose up to 26.51 months	All enrolled participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival	LY573636 Target Cmax 420 µg/mL		2.64	90% Confidence Interval 1.41 to 3.38	months
Progression-Free Survival	LY573636 Target Cmax 360 µg/mL		1.38	90% Confidence Interval 1.38 to 1.54	months
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	LY573636 Target Cmax 420 µg/mL	Complete Response (CR)	0.0	90% Confidence Interval NA to NA	percentage of participants
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	LY573636 Target Cmax 360 µg/mL	Complete Response (CR)	0.0	90% Confidence Interval NA to NA	percentage of participants
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	LY573636 Target Cmax 420 µg/mL	Partial Response (PR)	3.2	90% Confidence Interval 0.0 to 6.8	percentage of participants
Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)	LY573636 Target Cmax 360 µg/mL	Partial Response (PR)	2.6	90% Confidence Interval 0.0 to 6.9	percentage of participants
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)	LY573636 Target Cmax 420 µg/mL		46.0	90% Confidence Interval 35.7 to 56.4	percentage of participants
Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)	LY573636 Target Cmax 360 µg/mL		26.3	90% Confidence Interval 14.6 to 38.1	percentage of participants
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636	LY573636 Target Cmax 420 µg/mL	Cycle 1	386.0	Geometric Coefficient of Variation 14.0	micrograms/milliliter (µg/mL)
Pharmacokinetics: Maximum Concentration (Cmax) of LY573636	LY573636 Target Cmax 360 µg/mL	Cycle 1	325.7	Geometric Coefficient of Variation 14.5	micrograms/milliliter (µg/mL)

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	LY573636 Target Cmax 420 µg/mL	63
Overall Study	STARTED	LY573636 Target Cmax 360 µg/mL	38
Overall Study	COMPLETED	LY573636 Target Cmax 420 µg/mL	0
Overall Study	COMPLETED	LY573636 Target Cmax 360 µg/mL	0
Overall Study	NOT COMPLETED	LY573636 Target Cmax 420 µg/mL	63
Overall Study	NOT COMPLETED	LY573636 Target Cmax 360 µg/mL	38

Source ClinicalTrials.gov

Adverse events246

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	Anaemia	Blood and lymphatic system disorders	LY573636 Target Cmax 420 µg/mL	19	63	27
other	Anaemia	Blood and lymphatic system disorders	LY573636 Target Cmax 360 µg/mL	6	38	11
other	Leukopenia	Blood and lymphatic system disorders	LY573636 Target Cmax 420 µg/mL	20	63	26
other	Leukopenia	Blood and lymphatic system disorders	LY573636 Target Cmax 360 µg/mL	2	38	2
other	Lymphopenia	Blood and lymphatic system disorders	LY573636 Target Cmax 420 µg/mL	14	63	15
other	Lymphopenia	Blood and lymphatic system disorders	LY573636 Target Cmax 360 µg/mL	2	38	2
other	Neutropenia	Blood and lymphatic system disorders	LY573636 Target Cmax 420 µg/mL	15	63	27
other	Neutropenia	Blood and lymphatic system disorders	LY573636 Target Cmax 360 µg/mL	4	38	5
other	Thrombocytopenia	Blood and lymphatic system disorders	LY573636 Target Cmax 420 µg/mL	21	63	37
other	Thrombocytopenia	Blood and lymphatic system disorders	LY573636 Target Cmax 360 µg/mL	8	38	15

1 to 10 of 246Source ClinicalTrials.gov

See all 246 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LY573636 Target Cmax 420 µg/mL
Total, all-cause mortality	LY573636 Target Cmax 360 µg/mL
Total, other adverse events	LY573636 Target Cmax 420 µg/mL	59	63
Total, other adverse events	LY573636 Target Cmax 360 µg/mL	36	38
Total, serious adverse events	LY573636 Target Cmax 420 µg/mL	23	63
Total, serious adverse events	LY573636 Target Cmax 360 µg/mL	10	38

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22539091	DERIVED

Source 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 comparisons1

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

Comparison
LY573636 Target Cmax 420 µg/mL vs LY573636 Target Cmax 360 µg/mL: serious adverse events

Source 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/NCT00490451

GET https://conductscience.org/api/trials/v1/NCT00490451/events?page=2

API reference For AI assistants