Trial · NCT01609231
A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)
NCT01609231, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2020-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025). Trials, record NCT01609231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01609231
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)
- NCT number
- NCT01609231
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Rectal Neoplasms
- Interventions
- Dalotuzumab, Irinotecan, Cetuximab
- First posted
- 2012-05-31
- Last updated
- 2020-05-04
- Other registries' IDs
- eudract:2012-000317-36
- Results first posted
- 2020-05-04
- Limitations and caveats
- The study did not meet target enrollment and was terminated for business reasons; insufficient data were collected for efficacy analyses. Safety data are reported.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of Progression-free Survival (PFS) | From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years) | PFS is a measure of the time from randomization to the time of first documented disease progression (assessed by an independent Radiology Review Committee \[iRRC\]) or participant death, whichever occurs first. |
| Secondary | Percentage of Participants With Objective Response Rate (ORR) | From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years) | ORR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) during the course of the study using enhanced Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Confirmation of response was not required. |
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 | Assessment of Progression-free Survival (PFS) | From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years) | Due to low enrollment and early termination of study, insufficient data were collected for this endpoint, and no endpoint data were assessed by the iRRC. | ||
| SECONDARY | Percentage of Participants With Objective Response Rate (ORR) | From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years) | Due to low enrollment and early termination of study, insufficient data were collected for this endpoint, and no endpoint data were assessed for RECIST 1.1 criteria. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dalotuzumab + Irinotecan | 6 | |
| Overall Study | STARTED | Cetuximab + Irinotecan | 5 | |
| Overall Study | COMPLETED | Dalotuzumab + Irinotecan | 3 | |
| Overall Study | COMPLETED | Cetuximab + Irinotecan | 2 | |
| Overall Study | NOT COMPLETED | Dalotuzumab + Irinotecan | 3 | |
| Overall Study | NOT COMPLETED | Cetuximab + Irinotecan | 3 |
Source ClinicalTrials.gov
Adverse events202
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 | Anaemia | Blood and lymphatic system disorders | Dalotuzumab + Irinotecan | 2 | 6 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cetuximab + Irinotecan | 2 | 5 | 3 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Dalotuzumab + Irinotecan | 0 | 6 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cetuximab + Irinotecan | 1 | 5 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Dalotuzumab + Irinotecan | 1 | 6 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Cetuximab + Irinotecan | 1 | 5 | 1 |
| other | Ear discomfort | Ear and labyrinth disorders | Dalotuzumab + Irinotecan | 1 | 6 | 2 |
| other | Ear discomfort | Ear and labyrinth disorders | Cetuximab + Irinotecan | 0 | 5 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Dalotuzumab + Irinotecan | 1 | 6 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Cetuximab + Irinotecan | 0 | 5 | 0 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dalotuzumab + Irinotecan | 1 | 6 |
| Total, all-cause mortality | Cetuximab + Irinotecan | 2 | 5 |
| Total, other adverse events | Dalotuzumab + Irinotecan | 6 | 6 |
| Total, other adverse events | Cetuximab + Irinotecan | 5 | 5 |
| Total, serious adverse events | Dalotuzumab + Irinotecan | 1 | 6 |
| Total, serious adverse events | Cetuximab + Irinotecan | 4 | 5 |
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 |
|---|---|
| Dalotuzumab + Irinotecan vs Cetuximab + Irinotecan: deaths from any cause | Trial comparisons |
| Dalotuzumab + Irinotecan vs Cetuximab + Irinotecan: 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/NCT01609231
GET https://conductscience.org/api/trials/v1/NCT01609231/events?page=2