Trial · NCT01744340
A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer
NCT01744340, Phase 1, Phase 2, Completed, howard safran; results first posted 2016-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer. Trials, record NCT01744340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01744340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Finding Study of Eribulin Mesylate and Cetuximab For Patients With Advanced Head and Neck and Colon Cancer
- NCT number
- NCT01744340
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- howard safran
- Conditions
- Head and Neck Cancer, Colon Cancer
- Interventions
- Head and neck, Colon- Closed as of May 2014
- First posted
- 2012-12-06
- Last updated
- 2020-02-17
- Results first posted
- 2016-02-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer. | From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days | A DLT was defined as: * Grade 4 neutropenia (ANC \< 500/mm3) for \> 7 days * ANC \<1000/mm3 with fever or infection * Platelets \<25,000/mm3 * Platelets \<50,000/mm3 requiring transfusion * Grade 3 or grade 4 treatment related non-hematologic toxicities excluding alopecia. Grade 3 nausea, vomiting or diarrhea will only be considered a dose limiting toxicity if it occurs despite maximal medical support. Grade 3 or grade 4 hypomagnesemia will not be considered a dose limiting toxicity since it is an expected side effect of cetuximab and can be corrected. Other grade 3 or grade 4 electrolyte abnormalities will not be considered dose limiting toxicities if the electrolyte disorder can be corrected to grade 2 or less within 72 hours. * EGFR dermatologic toxicity should be graded according to the toxicity scale for EGFR associated reactions. The first episode of grade 3 or grade 4 rash will not be considered a DLT. * If any patient receives \< 70% of the planned dose of eribulin mesylat |
| Secondary | Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab. | From beginning of treatment to progression of disease, for an expected average of 1 year | This shows patients able to achieve Stable disease or better as their best response during course of study participation. Response will be evaluated by Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1 RECIST Guideline version 1.1 Response Criteria Complete Response:Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer. | From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days | Outcome measure that address the dose of 1.4 mg/m2,6 patients were treated (1 head and neck 5 colon). 12 patients were enrolled in the course of the MTD dose finding,10 colon and 2 head and neck. All other results sections are inclusive of all patients(dose finding +expansion cohort). | participants | NUMBER |
| SECONDARY | Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab. | From beginning of treatment to progression of disease, for an expected average of 1 year | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer. | Head and Neck | 0 | participants | ||
| If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer. | Colon- Closed as of May 2014 | 0 | participants | ||
| Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab. | Head and Neck | 6 | participants | ||
| Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab. | Colon- Closed as of May 2014 | 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 | Head and Neck | 8 | |
| Overall Study | STARTED | Colon- Closed as of May 2014 | 15 | |
| Overall Study | COMPLETED | Head and Neck | 8 | |
| Overall Study | COMPLETED | Colon- Closed as of May 2014 | 15 | |
| Overall Study | NOT COMPLETED | Head and Neck | 0 | |
| Overall Study | NOT COMPLETED | Colon- Closed as of May 2014 | 0 |
Source ClinicalTrials.gov
Adverse events172
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 | Albumin | Investigations | Head and Neck | 7 | 8 | 7 |
| other | Albumin | Investigations | Colon- Closed as of May 2014 | 7 | 15 | 7 |
| other | Allergic Rhinitis | Investigations | Head and Neck | 1 | 8 | 1 |
| other | Allergic Rhinitis | Investigations | Colon- Closed as of May 2014 | 0 | 15 | 0 |
| other | ALK | Investigations | Head and Neck | 0 | 8 | 0 |
| other | ALK | Investigations | Colon- Closed as of May 2014 | 2 | 15 | 2 |
| other | ALT | Investigations | Head and Neck | 2 | 8 | 2 |
| other | ALT | Investigations | Colon- Closed as of May 2014 | 5 | 15 | 5 |
| other | Alopecia | Investigations | Head and Neck | 2 | 8 | 2 |
| other | Alopecia | Investigations | Colon- Closed as of May 2014 | 2 | 15 | 2 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Head and Neck | ||
| Total, all-cause mortality | Colon- Closed as of May 2014 | ||
| Total, other adverse events | Head and Neck | 8 | 8 |
| Total, other adverse events | Colon- Closed as of May 2014 | 15 | 15 |
| Total, serious adverse events | Head and Neck | 5 | 8 |
| Total, serious adverse events | Colon- Closed as of May 2014 | 1 | 15 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Head and Neck vs Colon- Closed as of May 2014: If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer. | Trial comparisons |
Head and Neck vs Colon- Closed as of May 2014: Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab. | Trial comparisons |
| Head and Neck vs Colon- Closed as of May 2014: 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/NCT01744340
GET https://conductscience.org/api/trials/v1/NCT01744340/events?page=2