Trial · NCT00787267
Phase II Study of Dasatinib in Previously Treated Patients With Advanced NSCLC
NCT00787267, Phase 2, Terminated, Duke University; results first posted 2015-01-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Dasatinib in Previously Treated Patients With Advanced NSCLC. Trials, record NCT00787267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00787267
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Dasatinib in Previously Treated Patients With Advanced NSCLC
- NCT number
- NCT00787267
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Dasatinib
- First posted
- 2008-11-07
- Last updated
- 2016-06-30
- Results first posted
- 2015-01-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response | 2 years | Tumor response rate was defined by RECIST criteria: CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started |
| Secondary | Overall Survival | Progression and survival every 6 months | Overall survival (OS) is the duration from date of consent to date of death from any cause. |
| Secondary | Grade 3-5 Toxicity Associated With Dasatinib Treatment | Duration of dasatinib treatment plus 30 days | Number of subjects with Grade 3-5 toxicity as assessed using NCI CTCAE criteria with the attribution of possibly, probably, or definitely related to protocol treatment. |
| Secondary | Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib. | 2 years | |
| Secondary | Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib. | 2 years |
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 | Tumor Response | 2 years | Unable to determine the response for 9 subjects. | participants | NUMBER |
| SECONDARY | Overall Survival | Progression and survival every 6 months | All subjects who received at least one dose of dasatinib were included in the analysis. | months | MEDIAN |
| SECONDARY | Grade 3-5 Toxicity Associated With Dasatinib Treatment | Duration of dasatinib treatment plus 30 days | All subjects who received at least one dose of dasatinib were included in the analysis. | participants | NUMBER |
| SECONDARY | Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib. | 2 years | Assays were not run because no objective tumor response was observed. | ||
| SECONDARY | Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib. | 2 years | Assays were not run because no objective tumor response was observed. |
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 |
|---|---|---|---|---|---|
| Tumor Response | Dasatinib | Complete Response | 0 | participants | |
| Tumor Response | Dasatinib | Partial Response | 0 | participants | |
| Tumor Response | Dasatinib | Stable Disease | 5 | participants | |
| Tumor Response | Dasatinib | Progression of Disease | 11 | participants | |
| Overall Survival | Dasatinib | 3.7 | 95% Confidence Interval 2.3 to 5.9 | months | |
| Grade 3-5 Toxicity Associated With Dasatinib Treatment | 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 | 37 | |
| Overall Study | COMPLETED | Dasatinib | 25 | |
| Overall Study | NOT COMPLETED | Dasatinib | 12 |
Source ClinicalTrials.gov
Adverse events46
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 | anorexia | General disorders | Evalulable Patients That Received Dasatinib | 6 | 25 | |
| other | bronchospasm (wheezing) | Respiratory, thoracic and mediastinal disorders | Evalulable Patients That Received Dasatinib | 2 | 25 | |
| other | decreased hemoglobin | Blood and lymphatic system disorders | Evalulable Patients That Received Dasatinib | 8 | 25 | |
| other | decreased neutrophils | Blood and lymphatic system disorders | Evalulable Patients That Received Dasatinib | 1 | 25 | |
| other | diarrhea | Gastrointestinal disorders | Evalulable Patients That Received Dasatinib | 3 | 25 | |
| other | dizziness (lightheadedness) | General disorders | Evalulable Patients That Received Dasatinib | 1 | 25 | |
| other | dyspnea | Respiratory, thoracic and mediastinal disorders | Evalulable Patients That Received Dasatinib | 2 | 25 | |
| other | edema (periorbital/face) | General disorders | Evalulable Patients That Received Dasatinib | 1 | 25 | |
| other | elevated AST | Blood and lymphatic system disorders | Evalulable Patients That Received Dasatinib | 2 | 25 | |
| other | elevated creatinine | Renal and urinary disorders | Evalulable Patients That Received Dasatinib | 1 | 25 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Evalulable Patients That Received Dasatinib | ||
| Total, other adverse events | Evalulable Patients That Received Dasatinib | 25 | 25 |
| Total, serious adverse events | Evalulable Patients That Received Dasatinib | 17 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 16421553 | BACKGROUND |
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 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/NCT00787267
GET https://conductscience.org/api/trials/v1/NCT00787267/events?page=2