Trial · NCT00459342
Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
NCT00459342, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-12-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer. Trials, record NCT00459342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00459342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
- NCT number
- NCT00459342
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Interventions
- dasatinib
- First posted
- 2007-04-11
- Last updated
- 2019-03-05
- Results first posted
- 2013-12-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) | 12 weeks | Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): 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. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans. |
| Primary | Progression-free Survival (PFS) | Time from start of treatment to time of progression or death, assessed at 2 months | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. |
| Other | Time to Progression (TTP) | Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks | |
| Other | Epidermal Growth Factor Receptor (EGFR) Mutational Status | Baseline | |
| Other | Epidermal Growth Factor Receptor (EGFR) Copy Number | Baseline | |
| Other | Phospho-Src (pSrc) Expression | Baseline |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) | 12 weeks | Of the 34 eligible study participants enrolled, four participants were not evaluable for response. | participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) | Time from start of treatment to time of progression or death, assessed at 2 months | Four participants were not evaluable for response. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Time to Progression (TTP) | Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks | Seven patients discontinued dasatinib because of toxicity or unrelated medical problems (i.e., not progression) and are not evaluable for progression. | days | MEAN |
| OTHER_PRE_SPECIFIED | Epidermal Growth Factor Receptor (EGFR) Mutational Status | Baseline | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Epidermal Growth Factor Receptor (EGFR) Copy Number | Baseline | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Phospho-Src (pSrc) Expression | Baseline | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) | Dasatinib | Partial Remission | 1 | participants | |
| Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) | Dasatinib | Stable Disease | 12 | participants | |
| Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR)) | Dasatinib | Progressive Disease | 17 | participants | |
| Progression-free Survival (PFS) | Dasatinib | 1.36 | 95% Confidence Interval 0.16 to 17.2 | months | |
| Time to Progression (TTP) | Dasatinib | 92 | Standard Deviation 107 | days | |
| Epidermal Growth Factor Receptor (EGFR) Mutational Status | Dasatinib | EGFR mutant | 9 | participants | |
| Epidermal Growth Factor Receptor (EGFR) Mutational Status | Dasatinib | EGFR wild type | 22 | participants | |
| Epidermal Growth Factor Receptor (EGFR) Mutational Status | Dasatinib | EGFR not tested | 3 | participants | |
| Epidermal Growth Factor Receptor (EGFR) Copy Number | Dasatinib | EGFR amplfied | 3 | participants | |
| Epidermal Growth Factor Receptor (EGFR) Copy Number | Dasatinib | EGFR not amplified | 17 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 35 | |
| Overall Study | COMPLETED | Dasatinib | 34 | |
| Overall Study | NOT COMPLETED | Dasatinib | 1 |
Source ClinicalTrials.gov
Adverse events105
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 | Abdominal pain | General disorders | Dasatinib | 2 | 35 | 2 |
| other | Alanine aminotransferase increased | Blood and lymphatic system disorders | Dasatinib | 3 | 35 | 3 |
| other | Allergic rhinitis | Immune system disorders | Dasatinib | 2 | 35 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Dasatinib | 1 | 35 | 1 |
| other | Anal hemorrhage | Gastrointestinal disorders | Dasatinib | 1 | 35 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Dasatinib | 6 | 35 | 9 |
| other | Anorexia | Metabolism and nutrition disorders | Dasatinib | 16 | 35 | 17 |
| other | Anxiety | Psychiatric disorders | Dasatinib | 6 | 35 | 7 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Dasatinib | 2 | 35 | 2 |
| other | Aspartate aminotransferase increased | Endocrine disorders | Dasatinib | 3 | 35 | 3 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 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 | 34 | 35 |
| Total, serious adverse events | Dasatinib | 25 | 35 |
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
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/NCT00459342
GET https://conductscience.org/api/trials/v1/NCT00459342/events?page=2