Trial · NCT00882583
A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC
NCT00882583, Phase 1, Terminated, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC. Trials, record NCT00882583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00882583
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC
- NCT number
- NCT00882583
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Head and Neck Cancer
- Interventions
- Cetuximab, Dasatinib, Cisplatin, Radiation Therapy
- First posted
- 2009-04-16
- Last updated
- 2019-01-09
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Last day of Radiation | The Maximum Tolerated Dose (MTD) for Dasatinib was defined as a) the dose producing DLT ( Dose limiting toxicity) in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in \<2 out of 6 patients, or c) the dose of 150mg PO QD with less than 33% rate of DLT. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Last day of Radiation | MTD not reached. Data table reports dosage received by each participant. Study closed to slow accrual. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Cohort A | Dose 70 mg | 4 | Participants | |
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Cohort B | Dose 70 mg | 7 | Participants | |
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Cohort A | Dose 100mg | 3 | Participants | |
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Cohort B | Dose 100mg | 3 | Participants | |
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Cohort A | Dose 150mg | 0 | Participants | |
MTD of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A and Daily Oral Dasatinib in Combination With Cetuximab/Cis or Carboplatin/RT in Cohort B 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B | Cohort B | Dose 150mg | 2 | Participants |
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 | Cohort A T2N0, T1-2N1 SCCHN | 7 | |
| Overall Study | STARTED | Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN | 12 | |
| Overall Study | COMPLETED | Cohort A T2N0, T1-2N1 SCCHN | 6 | |
| Overall Study | COMPLETED | Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN | 11 | |
| Overall Study | NOT COMPLETED | Cohort A T2N0, T1-2N1 SCCHN | 1 | |
| Overall Study | NOT COMPLETED | Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN | 1 |
Source ClinicalTrials.gov
Adverse events66
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 | Peg tube site pain | Gastrointestinal disorders | Cohort A | 6 | 7 | 6 |
| other | Peg tube site pain | Gastrointestinal disorders | Cohort B | 4 | 12 | 4 |
| other | Nausea | Gastrointestinal disorders | Cohort A | 6 | 7 | 6 |
| other | Nausea | Gastrointestinal disorders | Cohort B | 11 | 12 | 11 |
| other | Vomiting | Gastrointestinal disorders | Cohort A | 3 | 7 | 3 |
| other | Vomiting | Gastrointestinal disorders | Cohort B | 8 | 12 | 8 |
| other | Constipation | Gastrointestinal disorders | Cohort A | 5 | 7 | 5 |
| other | Constipation | Gastrointestinal disorders | Cohort B | 10 | 12 | 10 |
| other | Rash | Skin and subcutaneous tissue disorders | Cohort A | 6 | 7 | 6 |
| other | Rash | Skin and subcutaneous tissue disorders | Cohort B | 12 | 12 | 12 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 1 | 7 |
| Total, all-cause mortality | Cohort B | 1 | 12 |
| Total, other adverse events | Cohort A | 7 | 7 |
| Total, other adverse events | Cohort B | 12 | 12 |
| Total, serious adverse events | Cohort A | 1 | 7 |
| Total, serious adverse events | Cohort B | 5 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A vs Cohort B: deaths from any cause | Trial comparisons |
| Cohort A vs Cohort B: serious adverse events | 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/NCT00882583
GET https://conductscience.org/api/trials/v1/NCT00882583/events?page=2