Trial · NCT00504153
Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer
NCT00504153, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer. Trials, record NCT00504153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00504153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer
- NCT number
- NCT00504153
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer
- Interventions
- dasatinib, laboratory biomarker analysis
- First posted
- 2007-07-19
- Last updated
- 2014-05-19
- Results first posted
- 2013-09-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Rate | From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.) | Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Patients who are still alive and have not progressed will be censored at the date of the last negative examination. A Simon (1989), optimal, two-stage design will be employed. The progression-free survival count will be the proportion of subjects who are alive and progression-free at 4 months. |
| Secondary | Response Rate (RR) (Complete or Partial Responders) | Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months) | Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. The response rate is the proportion of subjects who experienced a complete or partial response. |
| Secondary | Incidence of Somatic Mutations | 1 year | Multivariable analysis of progression-free survival duration will be performed using the Cox (1972) regression model to evaluate the prognostic value of somatic mutations. For the mutational analysis endpoints, genetic mutations will also be correlated with drug activity via Fisher's exact test for comparisons of responders with non-responders and for comparison of patients progression-free and 4 months vs. those with early progression or death |
| Secondary | Association Between the Incidence of Total C-src and Phosphorylated C-src Expression and Response | 4 months | Examined by comparing expression in those who have an objective response versus those who do not and in those with and without disease progression at 4 months using Fisher's exact test. |
| Secondary | Change in Plasma Vascular Endothelial Growth Factor (VEGF) Levels Over 15 Days | At baseline and day 15 | Changes of VEGF will be correlated with response rates and 4-month progression-free survival utilizing the Wilcoxon rank-sum test. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Rate | From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.) | percentage of participants | NUMBER | |
| SECONDARY | Response Rate (RR) (Complete or Partial Responders) | Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months) | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Somatic Mutations | 1 year | This outcome was not assessed for any of the patients. | ||
| SECONDARY | Association Between the Incidence of Total C-src and Phosphorylated C-src Expression and Response | 4 months | This outcome was not assessed for any of the patients. | ||
| SECONDARY | Change in Plasma Vascular Endothelial Growth Factor (VEGF) Levels Over 15 Days | At baseline and day 15 | This outcome was not assessed for any of the patients. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Rate | Dasatinib (Tyrosine Kinase Inhibitor) | 5.3 | percentage of participants | ||
| Response Rate (RR) (Complete or Partial Responders) | Dasatinib (Tyrosine Kinase Inhibitor) | 0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib (Tyrosine Kinase Inhibitor) | 19 | |
| Overall Study | COMPLETED | Dasatinib (Tyrosine Kinase Inhibitor) | 13 | |
| Overall Study | NOT COMPLETED | Dasatinib (Tyrosine Kinase Inhibitor) | 6 |
Source ClinicalTrials.gov
Adverse events43
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 | Alanine aminotransferase increased | Metabolism and nutrition disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Alkaline phosphatase (ALP) increased | Metabolism and nutrition disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Anemia | Blood and lymphatic system disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 2 | 19 | |
| other | Anorexia | Gastrointestinal disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Aspartate aminotransferase (AST) increased | Metabolism and nutrition disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Blood bilirubin increased | Blood and lymphatic system disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Blood infection | Infections and infestations | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Duodenal stenosis | Gastrointestinal disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 1 | 19 | |
| other | Fatigue | General disorders | Dasatinib (Tyrosine Kinase Inhibitor) | 3 | 19 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib (Tyrosine Kinase Inhibitor) | ||
| Total, other adverse events | Dasatinib (Tyrosine Kinase Inhibitor) | 17 | 19 |
| Total, serious adverse events | Dasatinib (Tyrosine Kinase Inhibitor) | 10 | 19 |
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 |
|---|---|---|---|---|---|
| P30CA014599 | Cancer Center Support Grant | ODUNSI, KUNLE | UNIVERSITY OF CHICAGO | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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.
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/NCT00504153
GET https://conductscience.org/api/trials/v1/NCT00504153/events?page=2