Trial · NCT00293215
Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen
NCT00293215, Phase 1, Terminated, Ludwig Institute for Cancer Research; results first posted 2020-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen. Trials, record NCT00293215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00293215
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen
- NCT number
- NCT00293215
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Ludwig Institute for Cancer Research
- Conditions
- Neoplasms
- Interventions
- 111-Indium-CMD-193, CMD-193
- First posted
- 2006-02-17
- Last updated
- 2022-10-10
- Results first posted
- 2020-08-10
- Limitations and caveats
- Following an interim review of primary endpoint data, the study was terminated early on the basis of abnormal distribution and lack of tumor targeting in both dose cohorts.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Up to 8 days | Biodistribution data were collected after subjects received a single infusion of 111-In-CMD-193 over 1 hour on Day 1 of Cycle 1. Gamma camera imaging with anterior and posterior whole body scans using conjugate view methodology were performed on Days 1, 2, 3 or 4, 5 or 6, and 7 or 8 following the 111-In-CMD-193 infusion. A standard was included in the field of view at each imaging time point. Single-photon emission computerized tomography (SPECT) imaging of relevant areas of disease were performed on at least one occasion following the 111-In-CMD-193 infusion. Biodistribution analysis was performed by examination of whole body and SPECT images by experienced nuclear medicine physicians. |
| Primary | Mean Effective Half-life of 111-In-CMD-193 Based on Gamma Camera Images | Up to 8 days | Gamma camera imaging with anterior and posterior whole body scans using conjugate view methodology were performed on Days 1, 2, 3 or 4, 5 or 6, and 7 or 8 following the 111-In-CMD-193 infusion. Whole body clearance, or biological half-time, was calculated from the whole body anterior and posterior planar images. A region of interest (ROI) was calculated to encompass the whole body, and for each ROI at each time point, the mean counts per pixel per minute was normalized to imaging time point Day 1. From this time-activity curve, an exponential clearance expression was fitted to obtain effective half-time. This was then corrected for the physical half-life of 111-In (67.45 hours) to account for physical decay to obtain the biological half-time. |
| Primary | Mean Serum Half-lives of 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | During Cycle 1 (111-In-CMD-193 infusion) serum samples for pharmacokinetics were collected on Days 1 (pre-infusion and 1 and 4 hours after the start of the infusion), 3, 8 and 15. Serum obtained from subjects following infusion of 111-In-CMD-193 was aliquoted and counted in a gamma scintillation counter. Duplicate standards prepared from the injected material were counted at each time point with serum samples to enable calculations to be corrected for the isotope physical decay. A 2-compartment IV bolus model with macro-parameters, no lag time and first order elimination (WNL Model 8) was fitted to individual labelled infusions for each subject using un-weighted nonlinear, least squares with WinNonLin version 5.2. T½α and T½β represent half lives of the initial and terminal phases of disposition. |
| Primary | Mean Volume of Central Compartment of 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | During Cycle 1 (111-In-CMD-193 infusion) serum samples for pharmacokinetics were collected on Days 1 (pre-infusion and 1 and 4 hours after the start of the infusion), 3, 8 and 15. Serum obtained from subjects following infusion of 111-In-CMD-193 was aliquoted and counted in a gamma scintillation counter. Duplicate standards prepared from the injected material were counted at each time point with serum samples to enable calculations to be corrected for the isotope physical decay. A 2-compartment IV bolus model with macro-parameters, no lag time and first order elimination (WNL Model 8) was fitted to individual labelled infusions for each subject using un-weighted nonlinear, least squares with WinNonLin version 5.2. |
| Primary | Mean Total Serum Clearance of 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | During Cycle 1 (111-In-CMD-193 infusion) serum samples for pharmacokinetics were collected on Days 1 (pre-infusion and 1 and 4 hours after the start of the infusion), 3, 8 and 15. Serum obtained from subjects following infusion of 111-In-CMD-193 was aliquoted and counted in a gamma scintillation counter. Duplicate standards prepared from the injected material were counted at each time point with serum samples to enable calculations to be corrected for the isotope physical decay. A 2-compartment IV bolus model with macro-parameters, no lag time and first order elimination (WNL Model 8) was fitted to individual labelled infusions for each subject using un-weighted nonlinear, least squares with WinNonLin version 5.2. |
| Primary | Mean Area Under the Serum Concentration Curve Extrapolated to Infinite Time for 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | During Cycle 1 (111-In-CMD-193 infusion) serum samples for pharmacokinetics were collected on Days 1 (pre-infusion and 1 and 4 hours after the start of the infusion), 3, 8 and 15. Serum obtained from subjects following infusion of 111-In-CMD-193 was aliquoted and counted in a gamma scintillation counter. Duplicate standards prepared from the injected material were counted at each time point with serum samples to enable calculations to be corrected for the isotope physical decay. A 2-compartment IV bolus model with macro-parameters, no lag time and first order elimination (WNL Model 8) was fitted to individual labelled infusions for each subject using un-weighted nonlinear, least squares with WinNonLin version 5.2. |
| Secondary | Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 4 months | Computed tomography (CT) scans were performed at screening, between Days 15 and 21 of Cycles 2 and 4, and at study completion. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16), and all response assessment was performed by a single experienced radiologist. Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. |
| Secondary | Number of Subjects With Best Metabolic Tumor Response by European Organisation for Research and Treatment of Cancer (EORTC) Guidelines at End of Study | Up to 4 months | Positron emission tomography with 18F-labeled fluorodeoxyglucose (18F-FDG-PET) was done at screening and between Days 15-21 of Cycles 2 and 4 or at study completion. Metabolic response was calculated using the target lesion with the greatest baseline standardized uptake value (SUV) and categorized per EORTC guidelines (Young et al. Eur J Cancer 1999;35:1773-82): progressive metabolic disease was an increase in 18F-FDG tumor maximum SUV (SUVmax) of \> 25% within the tumor ROI determined on baseline scans, visible increase in 18F-FDG tumor uptake (\>20% in the longest dimension) or new 18F-FDG uptake in metastatic lesions. Stable metabolic disease was an increase in tumor 18F-FDG SUVmax of \< 25% or decrease of \< 15% and no visible increase in 18F-FDG tumor uptake (\>20% in the longest dimension). Partial metabolic response was a reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle and \> 25% after \> 1 cycle (reduced tumor 18F-FDG uptake was not required). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Up to 8 days | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Effective Half-life of 111-In-CMD-193 Based on Gamma Camera Images | Up to 8 days | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | hours | MEAN |
| PRIMARY | Mean Serum Half-lives of 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | hours | MEAN |
| PRIMARY | Mean Volume of Central Compartment of 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | mL | MEAN |
| PRIMARY | Mean Total Serum Clearance of 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | mL/hr | MEAN |
| PRIMARY | Mean Area Under the Serum Concentration Curve Extrapolated to Infinite Time for 111-In-CMD-193 | Approximately 15 days (i.e., Days 1, 3, 8, and 15) | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | μg*hr/mL | MEAN |
| SECONDARY | Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) | Up to 4 months | All subjects who received at least 1 dose of study treatment and completed protocol procedures through at least 21 days following their first cycle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Best Metabolic Tumor Response by European Organisation for Research and Treatment of Cancer (EORTC) Guidelines at End of Study | Up to 4 months | All subjects who received at least 1 dose of study treatment and completed protocol procedures through at least 21 days following their first cycle. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 1 (1.0 mg/m^2) | Initial blood pooling | 6 | Participants | |
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 2 (2.6 mg/m^2) | Initial blood pooling | 3 | Participants | |
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 1 (1.0 mg/m^2) | Hepatic uptake by Day 2 persisting to Day 8 | 6 | Participants | |
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 2 (2.6 mg/m^2) | Hepatic uptake by Day 2 persisting to Day 8 | 3 | Participants | |
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 1 (1.0 mg/m^2) | Fast blood clearance | 6 | Participants | |
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 2 (2.6 mg/m^2) | Fast blood clearance | 3 | Participants | |
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 1 (1.0 mg/m^2) | Tumor uptake | 0 | Participants | |
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | Cohort 2 (2.6 mg/m^2) | Tumor uptake | 0 | Participants | |
| Mean Effective Half-life of 111-In-CMD-193 Based on Gamma Camera Images | Cohort 1 (1.0 mg/m^2) | 47.54 | Standard Deviation 3.16 | hours | |
| Mean Effective Half-life of 111-In-CMD-193 Based on Gamma Camera Images | Cohort 2 (2.6 mg/m^2) | 48.37 | Standard Deviation 4.03 | hours |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (1.0 mg/m^2) | 6 | |
| Overall Study | STARTED | Cohort 2 (2.6 mg/m^2) | 3 | |
| Overall Study | COMPLETED | Cohort 1 (1.0 mg/m^2) | 1 | |
| Overall Study | COMPLETED | Cohort 2 (2.6 mg/m^2) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 (1.0 mg/m^2) | 5 | |
| Overall Study | NOT COMPLETED | Cohort 2 (2.6 mg/m^2) | 3 |
Source ClinicalTrials.gov
Adverse events146
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 | Cohort 1 (1.0 mg/m^2) | 5 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 (2.6 mg/m^2) | 1 | 3 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 1 (1.0 mg/m^2) | 1 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 2 (2.6 mg/m^2) | 2 | 3 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1 (1.0 mg/m^2) | 1 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2 (2.6 mg/m^2) | 2 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1 (1.0 mg/m^2) | 6 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2 (2.6 mg/m^2) | 2 | 3 | |
| other | Gastroesophageal reflux | Gastrointestinal disorders | Cohort 1 (1.0 mg/m^2) | 2 | 6 | |
| other | Gastroesophageal reflux | Gastrointestinal disorders | Cohort 2 (2.6 mg/m^2) | 0 | 3 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (1.0 mg/m^2) | 0 | 6 |
| Total, all-cause mortality | Cohort 2 (2.6 mg/m^2) | 1 | 3 |
| Total, other adverse events | Cohort 1 (1.0 mg/m^2) | 6 | 6 |
| Total, other adverse events | Cohort 2 (2.6 mg/m^2) | 3 | 3 |
| Total, serious adverse events | Cohort 1 (1.0 mg/m^2) | 1 | 6 |
| Total, serious adverse events | Cohort 2 (2.6 mg/m^2) | 1 | 3 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 (1.0 mg/m^2) vs Cohort 2 (2.6 mg/m^2): deaths from any cause | Trial comparisons |
| Cohort 1 (1.0 mg/m^2) vs Cohort 2 (2.6 mg/m^2): 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/NCT00293215
GET https://conductscience.org/api/trials/v1/NCT00293215/results?page=2