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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (CR or PR) as Determined by the RECIST Criteria | Up 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 |
| Secondary | Progression-free Survival | From 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. |
| Secondary | Overall Survival | From the date of registration to the date of death, assessed up to 12 months | Will be estimated using the product-limit method of Kaplan and Meier by arm. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (CR or PR) as Determined by the RECIST Criteria | Up to 5 years | participants | NUMBER | |
| SECONDARY | Progression-free Survival | From the date of registration to the date of documented PSA progression, assessed up to 6 months | weeks | MEDIAN | |
| SECONDARY | Overall Survival | From the date of registration to the date of death, assessed up to 12 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (CR or PR) as Determined by the RECIST Criteria | Arm I | 0 | participants | ||
| Objective Response (CR or PR) as Determined by the RECIST Criteria | Arm II | 0 | participants | ||
| Progression-free Survival | Arm I | 7.0 | 95% Confidence Interval 6.3 to 7.3 | weeks | |
| Progression-free Survival | Arm II | 5.3 | 95% Confidence Interval 5.0 to 5.9 | weeks | |
| Overall Survival | Arm I | 3.6 | 95% Confidence Interval 2.5 to 8.2 | months | |
| Overall Survival | Arm II | 4.5 | 95% Confidence Interval 3.7 to 7.0 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I | 33 | |
| Overall Study | STARTED | Arm II | 31 | |
| Overall Study | COMPLETED | Arm I | 29 | |
| Overall Study | COMPLETED | Arm II | 30 | |
| Overall Study | NOT COMPLETED | Arm I | 4 | |
| Overall Study | NOT COMPLETED | Arm II | 1 |
Source ClinicalTrials.gov
Adverse events268
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I | 17 | 33 | 23 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II | 18 | 31 | 29 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I | 0 | 33 | 0 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II | 1 | 31 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Arm I | 1 | 33 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Arm II | 0 | 31 | 0 |
| other | Flashing vision | Eye disorders | Arm I | 0 | 33 | 0 |
| other | Flashing vision | Eye disorders | Arm II | 1 | 31 | 1 |
| other | Vision blurred | Eye disorders | Arm I | 0 | 33 | 0 |
| other | Vision blurred | Eye disorders | Arm II | 1 | 31 | 1 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, all-cause mortality | Arm II | ||
| Total, other adverse events | Arm I | 33 | 33 |
| Total, other adverse events | Arm II | 31 | 31 |
| Total, serious adverse events | Arm I | 14 | 33 |
| Total, serious adverse events | Arm II | 13 | 31 |
Source ClinicalTrials.gov
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.
| Comparison | Source |
|---|---|
| Arm I vs Arm II: Objective Response (CR or PR) as Determined by the RECIST Criteria | Trial comparisons |
| Arm I vs Arm II: 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.
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