Trial · NCT00608361
Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
NCT00608361, Phase 1, Completed, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery. Trials, record NCT00608361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608361
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
- NCT number
- NCT00608361
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 80 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Acute Lymphoblastic Leukemia in Remission, Adult B Acute Lymphoblastic Leukemia, Adult Hepatocellular Carcinoma, Adult Nasal Type Extranodal NK/T-Cell Lymphoma, Adult Solid Neoplasm, Adult T Acute Lymphoblastic Leukemia, Advanced Adult Hepatocellular Carcinoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-Cell Lymphoma, Chronic Lymphocytic Leukemia, Cutaneous B-Cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Hepatosplenic T-Cell Lymphoma, Intraocular Lymphoma, Localized Non-Resectable Adult Liver Carcinoma, Localized Resectable Adult Liver Carcinoma, Lymphomatous Involvement of Non-Cutaneous Extranodal Site, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Nodal Marginal Zone Lymphoma, Progressive Hairy Cell Leukemia Initial Treatment, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Lymphoma, Recurrent Adult Liver Carcinoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-Cell Leukemia/Lymphoma, Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides and Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestinal Lymphoma, Splenic Marginal Zone Lymphoma, Stage II Small Lymphocytic Lymphoma, Stage III Adult Burkitt Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Mixed Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage III Adult Immunoblastic Lymphoma, Stage III Adult Lymphoblastic Lymphoma, Stage III Adult T-Cell Leukemia/Lymphoma, Stage III Chronic Lymphocytic Leukemia, Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IIIA Mycosis Fungoides and Sezary Syndrome, Stage IIIB Mycosis Fungoides and Sezary Syndrome, Stage IV Adult Burkitt Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Mixed Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Adult Hodgkin Lymphoma, Stage IV Adult Immunoblastic Lymphoma, Stage IV Adult Lymphoblastic Lymphoma, Stage IV Adult T-Cell Leukemia/Lymphoma, Stage IV Chronic Lymphocytic Leukemia, Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Stage IVA Mycosis Fungoides and Sezary Syndrome, Stage IVB Mycosis Fungoides and Sezary Syndrome, T-Cell Large Granular Lymphocyte Leukemia, Testicular Lymphoma, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Hairy Cell Leukemia, Waldenstrom Macroglobulinemia
- Interventions
- Dasatinib, Pharmacological Study
- First posted
- 2008-02-06
- Last updated
- 2015-07-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose of dasatinib, defined as the highest dose level at which less than 33% of 6-9 evaluable patients experience dose-limiting toxicity | 28 days | Toxicity will be graded according to the NCI CTCAE v3.0. |
| Primary | Pharmacokinetic parameters of dasatinib | Days 1 and 8 of course 1 | Area under curve (AUC)(to infinity), AUC(to 24 hours), and maximum concentration (Cmax) analyzed in the natural log scale. For each PK parameter, the mean difference between the recommended dose for a liver impairment group and the normal liver function group dosed at 140 mg OD (equivalent to ratios of geometric means in the non-log scale) will be tested against 0 at a one-sided 0.05 significance level to detect an increase in the liver impairment group (equivalent to a 2-sided 90% confidence interval). |
| Other | Liver dysfunction data | Baseline | The Child-Pugh classification (CPC), NCI Organ Dysfunction Working Group (ODWG) Stratification Criteria for all patients will be collected at baseline and correlated to the toxicities and pharmacokinetic data seen with dasatinib in an exploratory analysis. Clearance estimates for each liver impairment group based upon the NCI ODWG Criteria, CPC Scheme, will be correlated with drug clearance. Ultimately, the predictive value of these various different methods of grouping organ dysfunction patients will be compared to determine if any method is better able to predict dasatinib clearance. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | 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/NCT00608361
GET https://conductscience.org/api/trials/v1/NCT00608361/registered