Trial · NCT01008475
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
NCT01008475, Phase 1, Phase 2, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2016-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer. Trials, record NCT01008475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01008475
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
- NCT number
- NCT01008475
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 232 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- EMD 525797 250 mg, EMD 525797 500 mg, EMD 525797 750 mg, EMD 525797 1000 mg, Cetuximab, Irinotecan
- First posted
- 2009-11-05
- Last updated
- 2016-03-30
- Results first posted
- 2016-03-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) | Time from the first dose of study drug up to 2 weeks | DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =\< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation. |
| Primary | Randomized Part: Progression Free Survival (PFS) | Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last. |
| Secondary | Overall Survival (OS) Time | Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first. |
| Secondary | Time to Progression (TTP) | Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last. |
| Secondary | Number of Subjects With Tumor Response | Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013) | Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. |
| Secondary | Time to Treatment Failure (TTF) | Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) | Time from the first dose of study drug up to 2 weeks | Dose-escalation analysis set included subjects who received atleast 1 dose of EMD 525797 and who met atleast 1 of the following: Did not withdraw before the end of DLT evaluation period (2 weeks from 1st drug intake) for reasons other than DLT;those who experienced a DLT during this period and received 1 dose of EMD 525797 as per cohort allocation. | subjects | NUMBER |
| PRIMARY | Randomized Part: Progression Free Survival (PFS) | Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | Intention-to-treat (ITT) analysis set included all the subjects who were randomized into the treatment groups. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) Time | Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | ITT analysis set included all the subjects who were randomized into the trial. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | ITT analysis set included all the subjects who were randomized into the trial. | months | MEDIAN |
| SECONDARY | Number of Subjects With Tumor Response | Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013) | ITT analysis set included all the subjects who were randomized into the trial. | Subjects | NUMBER |
| SECONDARY | Time to Treatment Failure (TTF) | Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013) | ITT analysis set included all the subjects who were randomized into the trial. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) | Safety Part: EMD 525797 250 mg + SoC | 0 | subjects | ||
| Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) | Safety Part: EMD 525797 500 mg + SoC | 0 | subjects | ||
| Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) | Safety Part: EMD525797 750 mg + SoC | 0 | subjects | ||
| Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) | Safety Part: EMD 525797 1000 mg +SoC | 0 | subjects | ||
| Randomized Part: Progression Free Survival (PFS) | Standard of Care (SoC) | 5.6 | 95% Confidence Interval 4.2 to 6.9 | months | |
| Randomized Part: Progression Free Survival (PFS) | EMD 525797 500 mg + SoC | 5.4 | 95% Confidence Interval 4.1 to 6.0 | months | |
| Randomized Part: Progression Free Survival (PFS) | EMD 525797 1000 mg + SoC | 5.6 | 95% Confidence Interval 4.1 to 6.9 | months | |
| Overall Survival (OS) Time | Standard of Care (SoC) | 11.6 | 95% Confidence Interval 9.8 to 15.7 | months | |
| Overall Survival (OS) Time | EMD 525797 500 mg + SoC | 15.0 | 95% Confidence Interval 10.9 to 19.2 | months | |
| Overall Survival (OS) Time | EMD 525797 1000 mg + SoC | 14.4 | 95% Confidence Interval 9.8 to 19.3 | months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Part: EMD 525797 250 mg + SoC | 3 | |
| Overall Study | STARTED | Safety Part: EMD 525797 500 mg + SoC | 3 | |
| Overall Study | STARTED | Safety Part: EMD525797 750 mg + SoC | 7 | |
| Overall Study | STARTED | Safety Part: EMD 525797 1000 mg +SoC | 3 | |
| Overall Study | STARTED | Randomized Part: Standard of Care (SoC) | 72 | |
| Overall Study | STARTED | Randomized Part: EMD 525797 500 mg + SoC | 73 | |
| Overall Study | STARTED | Randomized Part: EMD 525797 1000 mg + SoC | 71 | |
| Overall Study | Safety Analysis Set | Safety Part: EMD 525797 250 mg + SoC | 3 | |
| Overall Study | Safety Analysis Set | Safety Part: EMD 525797 500 mg + SoC | 3 | |
| Overall Study | Safety Analysis Set | Safety Part: EMD525797 750 mg + SoC | 7 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events3,584
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 | Agranulocytosis | Blood and lymphatic system disorders | Safety Part: EMD 525797 250 mg + SoC | 0 | 3 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | Safety Part: EMD 525797 500 mg + SoC | 0 | 3 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | Safety Part: EMD525797 750 mg + SoC | 0 | 7 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | Safety Part: EMD 525797 1000 mg +SoC | 0 | 3 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | Standard of Care (SoC) | 1 | 73 | 1 |
| other | Agranulocytosis | Blood and lymphatic system disorders | EMD 525797 500 mg + SoC | 0 | 72 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | EMD 525797 1000 mg + SoC | 0 | 69 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Safety Part: EMD 525797 250 mg + SoC | 1 | 3 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Safety Part: EMD 525797 500 mg + SoC | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Safety Part: EMD525797 750 mg + SoC | 0 | 7 | 0 |
1 to 10 of 3,584Source ClinicalTrials.gov
See all 3,584 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Part: EMD 525797 250 mg + SoC | ||
| Total, all-cause mortality | Safety Part: EMD 525797 500 mg + SoC | ||
| Total, all-cause mortality | Safety Part: EMD525797 750 mg + SoC | ||
| Total, all-cause mortality | Safety Part: EMD 525797 1000 mg +SoC | ||
| Total, all-cause mortality | Standard of Care (SoC) | ||
| Total, all-cause mortality | EMD 525797 500 mg + SoC | ||
| Total, all-cause mortality | EMD 525797 1000 mg + SoC | ||
| Total, other adverse events | Safety Part: EMD 525797 250 mg + SoC | 3 | 3 |
| Total, other adverse events | Safety Part: EMD 525797 500 mg + SoC | 3 | 3 |
| Total, other adverse events | Safety Part: EMD525797 750 mg + SoC | 7 | 7 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25319061 | DERIVED |
Source PubMed
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/NCT01008475
GET https://conductscience.org/api/trials/v1/NCT01008475/results?page=2