Trial · NCT00470054
Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
NCT00470054, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer. Trials, record NCT00470054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00470054
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
- NCT number
- NCT00470054
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- Interventions
- dasatinib
- First posted
- 2007-05-07
- Last updated
- 2015-05-05
- Results first posted
- 2013-04-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 Week Progression Free Survival | 6 weeks | Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions. |
| Secondary | Progression Free Survival (PFS) | Time from registration to progression (up to 3 years) | PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure. |
| Secondary | Response to Therapy | Assessed every 2 cycles (up to 3 years) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; * Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; * Stable Disease (SD): small changes that do not meet above criteria. |
| Secondary | Overall Survival | Time from registration to death (up to 3 years) | Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. |
| Secondary | Number of Participants With Grade 3 or Higher Adverse Events | Assessed during treatment | The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. |
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 | 6 Week Progression Free Survival | 6 weeks | All eligible participants were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Time from registration to progression (up to 3 years) | All eligible participants were analyzed. | weeks | MEDIAN |
| SECONDARY | Response to Therapy | Assessed every 2 cycles (up to 3 years) | All eligible participants were analyzed. | participants | NUMBER |
| SECONDARY | Overall Survival | Time from registration to death (up to 3 years) | All eligible participants were analyzed. | weeks | MEDIAN |
| SECONDARY | Number of Participants With Grade 3 or Higher Adverse Events | Assessed during treatment | All 44 participants who received treatment were analyzed (including ineligible participants). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6 Week Progression Free Survival | Dasatinib | 43 | 95% Confidence Interval 30 to 61 | percentage of participants | |
| Progression Free Survival (PFS) | Dasatinib | 5.9 | 95% Confidence Interval 5.7 to 6.6 | weeks | |
| Response to Therapy | Dasatinib | Complete Response | 0 | participants | |
| Response to Therapy | Dasatinib | Partial Response | 0 | participants | |
| Response to Therapy | Dasatinib | Stable Disease | 7 | participants | |
| Response to Therapy | Dasatinib | Progression | 28 | participants | |
| Response to Therapy | Dasatinib | Inadequately assessed | 8 | participants | |
| Overall Survival | Dasatinib | 17 | 95% Confidence Interval 14.6 to 29.7 | weeks | |
| Number of Participants With Grade 3 or Higher Adverse Events | Dasatinib | 12 | 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 | 44 | |
| Overall Study | COMPLETED | Dasatinib | 43 | |
| Overall Study | NOT COMPLETED | Dasatinib | 1 |
Source ClinicalTrials.gov
Adverse events118
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 | Blood and lymphatic system disorders | Dasatinib | 24 | 44 | 45 |
| other | Lymphatics - Other | Blood and lymphatic system disorders | Dasatinib | 1 | 44 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Dasatinib | 1 | 44 | 1 |
| other | Cataract | Eye disorders | Dasatinib | 1 | 44 | 2 |
| other | Ocular/Visual - Other | Eye disorders | Dasatinib | 1 | 44 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dasatinib | 1 | 44 | 1 |
| other | Constipation | Gastrointestinal disorders | Dasatinib | 6 | 44 | 8 |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib | 11 | 44 | 13 |
| other | Dyspepsia | Gastrointestinal disorders | Dasatinib | 2 | 44 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Dasatinib | 1 | 44 | 1 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Dasatinib | 39 | 44 |
| Total, serious adverse events | Dasatinib | 14 | 44 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA014236 | Cancer Center Support Grant (CCSG) | KASTAN, MICHAEL B | DUKE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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/NCT00470054
GET https://conductscience.org/api/trials/v1/NCT00470054/events?page=2