Trial · NCT01488318
Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
NCT01488318, Phase 2, Terminated, Julie E. Bauman, MD, MPH; results first posted 2018-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma. Trials, record NCT01488318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488318
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
- NCT number
- NCT01488318
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Julie E. Bauman, MD, MPH
- Conditions
- Squamous Cell Carcinoma Of The Head And Neck
- Interventions
- Cetuximab, Dasatinib
- First posted
- 2011-12-08
- Last updated
- 2018-01-05
- Results first posted
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 36 months | Number of patients experiencing a Complete Response (CR) + Partial Response (PR) to study treatment / Total number of evaluable patients, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Primary | Response to Treatment | Up to 36 months | Response of evaluable patients to treatment, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Secondary | Progression-free Survival (PFS) | Up to 36 months | |
| Secondary | Overall Survival (OS) | Up to 60 months | From date of entry into the study until the date of death from any cause, assessed up to 60 months. |
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 | Overall Response Rate (ORR) | Up to 36 months | Patients that received Cetuximab dosed at 250 mg/m\^2/week and Dasatinib 150 mg daily who were evaluable for response. | percentage of participants | NUMBER |
| PRIMARY | Response to Treatment | Up to 36 months | Patients that received Cetuximab dosed at 250 mg/m\^2/week and Dasatinib 150 mg daily who were evaluable for response. | participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Up to 36 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 60 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | CETUXIMAB + DASATINIB | 0 | percentage of participants | ||
| Response to Treatment | CETUXIMAB + DASATINIB | Patients experiencing Stable Disease (SD) | 5 | participants | |
| Response to Treatment | CETUXIMAB + DASATINIB | Patients experiencing Progressive Disease (PD) | 8 | participants | |
| Progression-free Survival (PFS) | CETUXIMAB + DASATINIB | 1.7 | 90% Confidence Interval 1.4 to 3.9 | months | |
| Overall Survival (OS) | CETUXIMAB + DASATINIB | 5.1 | 90% Confidence Interval 4.2 to 11.5 | months |
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 | CETUXIMAB + DASATINIB | 14 | |
| Overall Study | COMPLETED | CETUXIMAB + DASATINIB | 14 | |
| Overall Study | NOT COMPLETED | CETUXIMAB + DASATINIB | 0 |
Source ClinicalTrials.gov
Adverse events96
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 | Leukocytosis | Blood and lymphatic system disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Atrial fibrillation | Cardiac disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Heart failure | Cardiac disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Ear pain | Ear and labyrinth disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Tinnitus | Ear and labyrinth disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Eye disorders - Other, specify | Eye disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Dyspepsia | Gastrointestinal disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Mucositis oral | Gastrointestinal disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Oral dysesthesia | Gastrointestinal disorders | CETUXIMAB + DASATINIB | 1 | 14 | |
| other | Edema face | General disorders | CETUXIMAB + DASATINIB | 1 | 14 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CETUXIMAB + DASATINIB | 8 | 14 |
| Total, other adverse events | CETUXIMAB + DASATINIB | 12 | 14 |
| Total, serious adverse events | CETUXIMAB + DASATINIB | 8 | 14 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01488318
GET https://conductscience.org/api/trials/v1/NCT01488318/events?page=2