Trial · NCT00848510
EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases
NCT00848510, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2015-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases. Trials, record NCT00848510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848510
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases
- NCT number
- NCT00848510
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 41 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Colorectal and Ovarian Cancer Patients With Liver Metastases
- Interventions
- EMD 525797
- First posted
- 2009-02-20
- Last updated
- 2015-12-14
- Other registries' IDs
- eudract:2008-001820-30
- Results first posted
- 2015-12-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Dose Limiting Toxicities (DLTs) | Up to Week 4 | Toxicity was graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. A DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring during the first 4 weeks of treatment (that is, until the beginning of Week 5, with the exception of Grade 3 asymptomatic increase in liver function tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and alkaline phosphatase \[ALP\]) returning to Baseline within 7 days.), at any dose level, for which a causal relationship to the investigative medicinal product could not be ruled out by the Investigator and/or the Sponsor. |
| Primary | Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | Volume transfer coefficient was defined as the volume transfer coefficient of contrast agent across the capillary wall, reflecting endothelial permeability and blood flow. Volumetric transfer coefficient was measured by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). DCE-MRI is a noninvasive quantitative method of investigating microvascular structure and function by tracking the pharmacokinetics of injected low molecular weight contrast agents as they pass through tumor vasculature. |
| Primary | Blood Plasma Volume and Extravascular/Extracellular Volume | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | Blood plasma volume and extracellular/extravascular volume was measured using DCE-MRI. |
| Primary | Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60) | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | IAUC 60 was used to give a gross indication of the delivery and uptake of contrast agent within the tumor (indicating the degree of perfusion and endothelial permeability. IAUC60 was measured using DCE-MRI. |
| Primary | Whole Tumor Volume and Enhancing Tumor Volume | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | Tumor volume (three-dimensional measurement) and the enhancing fraction of the tumor, which provides a gross measure of the proportion of the tumor that has a measurable level of perfusion, were assessed using DCE-MRI. |
| Secondary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | From the initiation of the trial treatment until 30 days after last administration of trial treatment. | An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit | Up to 4 years | Tumor response was assessed by the Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria. Tumor response was defined as the presence of a "best overall response" of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions and/or normalization of serum levels of tumor markers. PR: At least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD of target lesions. The qualification of a CR or of a PR needed a confirmation by a second computed tomography (CT) scan at least 4 weeks after the first scan. Best overall response was derived programmatically as the best response recorded from the first investigation medicinal product administration until disease progression. Clinical benefit was defined as the presence of a "best overall response" of complete response or partial response or stable disease lasting at least 6 weeks. |
| Secondary | Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score | Up to 4 weeks after last dose administration | The number of subjects who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled. |
| Secondary | Number of Subjects With Positive Binding Abituzumab Antibodies | Day 1 of Weeks 1, 3, 5, 6, 7, 8, and week 11 and end of study (EOS) visit (4 weeks after last dose administration) | Subjects were defined as abituzumab positive if at least one positive result of antibodies against abituzumab was observed. In all other cases, subjects were defined as abituzumab negative. |
| Secondary | Progression-Free Survival (PFS) Time | Time from first study drug intake to disease progression, death or last tumor assessment until end of trial visit (4 weeks after last dose administration) | PFS was defined as the time from first study drug intake until radiological progression (based on RECIST Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Subjects without event were censored on the date of last tumor assessment. Investigator read was the assessment of all imaging by the treating physician at the local trial site. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Dose Limiting Toxicities (DLTs) | Up to Week 4 | Dose escalation analysis set included all subjects in the safety analysis set who experienced any DLT during the DLT observation period, regardless of the number of investigational medicinal product (IMP) administrations and subjects who received the IMP at Weeks 1, 3, and 5 for Cohort 1 and at Weeks 1 and 3 for all other cohorts. | Subjects | NUMBER |
| PRIMARY | Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan. | min^-1 | MEAN |
| SECONDARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | From the initiation of the trial treatment until 30 days after last administration of trial treatment. | The safety analysis set included all subjects who received at least one dose of IMP administration. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit | Up to 4 years | The full analysis set included all subjects who received at least one dose of IMP administration. N signifies the total number of participants evaluable for this outcome measure. Same subjects may be reported in more than one category. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score | Up to 4 weeks after last dose administration | The safety analysis set included all subjects who received at least one dose of IMP administration. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Positive Binding Abituzumab Antibodies | Day 1 of Weeks 1, 3, 5, 6, 7, 8, and week 11 and end of study (EOS) visit (4 weeks after last dose administration) | The immunogenicity analysis set included all subjects who received at least one dose of study drug administration and provided sufficient data from the antibodies samples. 'N' (number of subjects analyzed) signifies the subjects evaluable for this outcome measure. n signifies the number of subjects evaluable for each time point, respectively. | Subjects | NUMBER |
| PRIMARY | Blood Plasma Volume and Extravascular/Extracellular Volume | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan. | milliliter | MEAN |
| PRIMARY | Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60) | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan. | (Millimoles/liter)*sec | MEAN |
| PRIMARY | Whole Tumor Volume and Enhancing Tumor Volume | Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1 | The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan. | Cubic millimeter (mm^3) | MEAN |
| SECONDARY | Progression-Free Survival (PFS) Time | Time from first study drug intake to disease progression, death or last tumor assessment until end of trial visit (4 weeks after last dose administration) | The safety analysis set included all subjects who received at least one dose of IMP administration. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Dose Limiting Toxicities (DLTs) | Abituzumab 250 mg | 1 | Subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLTs) | Abituzumab 500 mg | 1 | Subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLTs) | Abituzumab 1000 mg | 0 | Subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLTs) | Abituzumab 1500 mg | 2 | Subjects | ||
| Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Abituzumab 250 mg | Screening 1 | 0.233 | Standard Deviation 0.0817 | min^-1 |
| Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Abituzumab 500 mg | Screening 1 | 0.214 | Standard Deviation 0.1385 | min^-1 |
| Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Abituzumab 1000 mg | Screening 1 | 0.221 | Standard Deviation 0.0991 | min^-1 |
| Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Abituzumab 1500 mg | Screening 1 | 0.141 | Standard Deviation 0.0650 | min^-1 |
| Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Abituzumab 250 mg | Screening 2 | 0.253 | Standard Deviation 0.1219 | min^-1 |
| Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls | Abituzumab 500 mg | Screening 2 | 0.177 | Standard Deviation 0.1450 | min^-1 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abituzumab 250 mg | 10 | |
| Overall Study | STARTED | Abituzumab 500 mg | 13 | |
| Overall Study | STARTED | Abituzumab 1000 mg | 8 | |
| Overall Study | STARTED | Abituzumab 1500 mg | 10 | |
| Overall Study | COMPLETED | Abituzumab 250 mg | 10 | |
| Overall Study | COMPLETED | Abituzumab 500 mg | 13 | |
| Overall Study | COMPLETED | Abituzumab 1000 mg | 8 | |
| Overall Study | COMPLETED | Abituzumab 1500 mg | 10 | |
| Overall Study | NOT COMPLETED | Abituzumab 250 mg | 0 | |
| Overall Study | NOT COMPLETED | Abituzumab 500 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events492
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 | Abituzumab 250 mg | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Abituzumab 500 mg | 1 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Abituzumab 1000 mg | 3 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Abituzumab 1500 mg | 1 | 10 | |
| other | Hypochromic Anaemia | Blood and lymphatic system disorders | Abituzumab 250 mg | 1 | 10 | |
| other | Hypochromic Anaemia | Blood and lymphatic system disorders | Abituzumab 500 mg | 0 | 13 | |
| other | Hypochromic Anaemia | Blood and lymphatic system disorders | Abituzumab 1000 mg | 0 | 8 | |
| other | Hypochromic Anaemia | Blood and lymphatic system disorders | Abituzumab 1500 mg | 0 | 10 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Abituzumab 250 mg | 0 | 10 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Abituzumab 500 mg | 1 | 13 |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abituzumab 250 mg | ||
| Total, all-cause mortality | Abituzumab 500 mg | ||
| Total, all-cause mortality | Abituzumab 1000 mg | ||
| Total, all-cause mortality | Abituzumab 1500 mg | ||
| Total, other adverse events | Abituzumab 250 mg | 10 | 10 |
| Total, other adverse events | Abituzumab 500 mg | 13 | 13 |
| Total, other adverse events | Abituzumab 1000 mg | 8 | 8 |
| Total, other adverse events | Abituzumab 1500 mg | 10 | 10 |
| Total, serious adverse events | Abituzumab 250 mg | 5 | 10 |
| Total, serious adverse events | Abituzumab 500 mg | 7 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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
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GET https://conductscience.org/api/trials/v1/NCT00848510
GET https://conductscience.org/api/trials/v1/NCT00848510/results?page=2