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Trial · NCT00103311

SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer

NCT00103311, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-03-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer. Trials, record NCT00103311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103311

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Trial

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

Title
SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer
NCT number
NCT00103311
Status
Completed
Phases
Phase 2
Enrollment
64 participants, actual
Lead sponsor
National Cancer Institute (NCI)
Conditions
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer
Interventions
ispinesib, laboratory biomarker analysis
First posted
2005-02-08
Last updated
2015-03-02
Results first posted
2015-03-02

Source ClinicalTrials.gov

Registered outcomes3

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

ListOutcomeTime frameDescription
PrimaryObjective Response (CR or PR) as Determined by the RECIST CriteriaUp to 5 years
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; Overall Response (OR) = CR + PR
SecondaryProgression-free SurvivalFrom the date of registration to the date of documented PSA progression, assessed up to 6 months
Will be estimated using the product-limit method of Kaplan and Meier by arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 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.
SecondaryOverall SurvivalFrom the date of registration to the date of death, assessed up to 12 monthsWill be estimated using the product-limit method of Kaplan and Meier by arm.

Outcomes3

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYObjective Response (CR or PR) as Determined by the RECIST CriteriaUp to 5 yearsparticipantsNUMBER
SECONDARYProgression-free SurvivalFrom the date of registration to the date of documented PSA progression, assessed up to 6 monthsweeksMEDIAN
SECONDARYOverall SurvivalFrom the date of registration to the date of death, assessed up to 12 monthsmonthsMEDIAN

Results by group6

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

OutcomeGroupCategoryValueSpreadUnits
Objective Response (CR or PR) as Determined by the RECIST CriteriaArm I0participants
Objective Response (CR or PR) as Determined by the RECIST CriteriaArm II0participants
Progression-free SurvivalArm I7.095% Confidence Interval 6.3 to 7.3weeks
Progression-free SurvivalArm II5.395% Confidence Interval 5.0 to 5.9weeks
Overall SurvivalArm I3.695% Confidence Interval 2.5 to 8.2months
Overall SurvivalArm II4.595% Confidence Interval 3.7 to 7.0months

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDArm I33
Overall StudySTARTEDArm II31
Overall StudyCOMPLETEDArm I29
Overall StudyCOMPLETEDArm II30
Overall StudyNOT COMPLETEDArm I4
Overall StudyNOT COMPLETEDArm II1

Adverse events268

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHemoglobin decreasedBlood and lymphatic system disordersArm I173323
otherHemoglobin decreasedBlood and lymphatic system disordersArm II183129
otherHemolysisBlood and lymphatic system disordersArm I0330
otherHemolysisBlood and lymphatic system disordersArm II1312
otherAtrial fibrillationCardiac disordersArm I1331
otherAtrial fibrillationCardiac disordersArm II0310
otherFlashing visionEye disordersArm I0330
otherFlashing visionEye disordersArm II1311
otherVision blurredEye disordersArm I0330
otherVision blurredEye disordersArm II1311

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityArm I
Total, all-cause mortalityArm II
Total, other adverse eventsArm I3333
Total, other adverse eventsArm II3131
Total, serious adverse eventsArm I1433
Total, serious adverse eventsArm II1331

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 comparisons2

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

ComparisonSource
Arm I vs Arm II: Objective Response (CR or PR) as Determined by the RECIST CriteriaTrial comparisons
Arm I vs Arm II: serious adverse eventsTrial 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/NCT00103311

GET https://conductscience.org/api/trials/v1/NCT00103311/events?page=2