Trial · NCT00563290
Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia
NCT00563290, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia. Trials, record NCT00563290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00563290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia
- NCT number
- NCT00563290
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin, Stage 0 Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia
- Interventions
- dasatinib, laboratory biomarker analysis
- First posted
- 2007-11-26
- Last updated
- 2015-06-18
- Results first posted
- 2015-03-20
- Limitations and caveats
- 3 patients were treated with Dasatinib 100 mg PO twice daily and 4 patients were treated with Daatinib 70 mg PO twice daily.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Complete Response and Partial Response) | Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment | 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 | Time from start of treatment to time of progression, assessed up to 12 weeks | 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 | Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC) | At baseline | Performed per standard protocols by the Pathology Department. |
| Secondary | COX-2 Presence by IHC | At baseline | Performed per standard protocols by the Pathology Department. Samples will be obtained pre-therapy. Determination of the COX-2 tumor status on this trial will develop the beginnings of a data base upon which future therapy may be designed. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Complete Response and Partial Response) | Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment | percentage of patients | NUMBER | |
| SECONDARY | Progression-free Survival | Time from start of treatment to time of progression, assessed up to 12 weeks | The second treatment arm of Dasatinib 70 mg orally twice a day was created as a result of an amendment to the protocol therefore the patient PFS data was combined for each arm. | weeks | MEDIAN |
| SECONDARY | Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC) | At baseline | Funding was not available to do correlative studies | ||
| SECONDARY | COX-2 Presence by IHC | At baseline | Funding was not available to do correlative studies |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Complete Response and Partial Response) | Arm I: Dasatinib | 0 | percentage of patients | ||
| Objective Response Rate (Complete Response and Partial Response) | Arm II: Dasatinib | 0 | percentage of patients | ||
| Progression-free Survival | Arm I and Arm II | 4 | Full Range 4 to 8 | weeks |
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 Dasatinib | 3 | |
| Overall Study | STARTED | Arm II Dasatinib | 4 | |
| Overall Study | COMPLETED | Arm I Dasatinib | 3 | |
| Overall Study | COMPLETED | Arm II Dasatinib | 4 | |
| Overall Study | NOT COMPLETED | Arm I Dasatinib | 0 | |
| Overall Study | NOT COMPLETED | Arm II Dasatinib | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Hemorrhage/Bleeding | Blood and lymphatic system disorders | Dasatinib 100 mg | 1 | 3 | 1 |
| other | Hemorrhage/Bleeding | Blood and lymphatic system disorders | Dasatinib 70 mg | 0 | 4 | 0 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Dasatinib 100 mg | 1 | 3 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Dasatinib 70 mg | 0 | 4 | 0 |
| other | Thrombosis/thrombus/embolism | Vascular disorders | Dasatinib 100 mg | 1 | 3 | 1 |
| other | Thrombosis/thrombus/embolism | Vascular disorders | Dasatinib 70 mg | 0 | 4 | 0 |
| other | Vascular- other | Vascular disorders | Dasatinib 100 mg | 1 | 3 | 1 |
| other | Vascular- other | Vascular disorders | Dasatinib 70 mg | 0 | 4 | 0 |
| other | Pneumonia | Infections and infestations | Dasatinib 100 mg | 0 | 3 | 0 |
| other | Pneumonia | Infections and infestations | Dasatinib 70 mg | 1 | 4 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib 100 mg | ||
| Total, all-cause mortality | Dasatinib 70 mg | ||
| Total, other adverse events | Dasatinib 100 mg | 1 | 3 |
| Total, other adverse events | Dasatinib 70 mg | 1 | 4 |
| Total, serious adverse events | Dasatinib 100 mg | 0 | 3 |
| Total, serious adverse events | Dasatinib 70 mg | 0 | 4 |
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 |
|---|---|---|---|---|---|
| P30CA016058 | Cancer Center Support Grant | RATHMELL, WENDY KIMRYN | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dasatinib 100 mg vs Dasatinib 70 mg: serious adverse events |
Source 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/NCT00563290
GET https://conductscience.org/api/trials/v1/NCT00563290/registered