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Abnormal distribution and lack of tumor targeting were observed.
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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium [111-In]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.
Subjects received a single infusion of 111-In-CMD-193 on Day 1. Collection of blood for PK and whole body gamma camera imaging for assessment of biodistribution and tumor uptake were performed on Days 1, 2, 3 or 4, 5 or 6, and 7 or 8 following the 111-In-CMD-193 infusion. Subjects were evaluated for safety for 3 hours post-infusion on Day 1 of each cycle, with subsequent safety assessments performed on Days 8 and 15. Blood for human anti-human antibody (HAHA) response was collected pre-infusion, prior to each subsequent cycle (every 3 weeks) and at study discontinuation.
CMD-193 was administered on Day 1 of each subsequent 21-day cycle as a 60 (± 5) minute intravenous (IV) infusion at a dose of 1.0 mg/m^2 in Cohort 1 and 2.6 mg/m^2 in Cohort 2. Each subject received up to 6 cycles of CMD-193 (including the initial infusion of 111-In-CMD-193) until disease progression, unacceptable toxicity, or withdrawal of consent. Up to 6 additional cycles of CMD-193 were permitted if approved by the Sponsor in subjects who tolerated CMD-193 treatment and had evidence of response. Pretreatment medications (e.g., paracetamol, promethazine hydrochloride) were to be administered to reduce the incidence and severity of an anticipated infusion syndrome characterized by fever and chills, and less commonly hypotension.
Restaging by computed tomography (CT) scan was performed at the end of Cycles 2, 4, and 6. Assessment of tumor metabolism was performed by positron emission tomography with 18F-labeled fluorodeoxyglucose (18F-FDG-PET) prior to Cycle 1 and at the time of restaging at the end of Cycles 2 and 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (1.0 mg/m^2) | Experimental | Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 on Day 1 of subsequent 21-day cycles. |
|
| Cohort 2 (2.6 mg/m^2) | Experimental | Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 on Day 1 of subsequent 21-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 111-Indium-CMD-193 | Drug | 111-In-CMD-193 (3-7 mCi) was administered as an IV infusion over 60 (± 5) minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | 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. | Up to 8 days |
| Mean Effective Half-life of 111-In-CMD-193 Based on Gamma Camera Images | 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. | Up to 8 days |
| Mean Serum Half-lives of 111-In-CMD-193 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) | 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. |
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Inclusion criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| A/Prof. Andrew M Scott, MBBS MD DDU | Ludwig Institute for Cancer Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Care Services, Dept. of Medical Oncology, Royal Brisbane and Women's Hospital | Herston | Queensland | 4209 | Australia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10655437 | Background | Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205. | |
| 10673991 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (1.0 mg/m^2) | Subjects received Indium-111 labelled-CMD-193 (111-In-CMD-193) (3-7 mCi) intravenously (IV) on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles. |
| FG001 | Cohort 2 (2.6 mg/m^2) | Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (1.0 mg/m^2) | Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles. |
| BG001 | Cohort 2 (2.6 mg/m^2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of 111-In-CMD-193 Biodistribution Based on Gamma Camera Images | 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. | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | Posted | Count of Participants | Participants | Up to 8 days |
|
All adverse events (AEs) occurring between the first dose of study treatment and the off-study date (i.e., up to 4 months) were documented, regardless of the causal relationship to study drug.
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 3.0), seriousness, relationship to study drug, study drug action taken, treatment, and outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (1.0 mg/m^2) | Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Skipper PhD | Ludwig Institute for Cancer Research | (212) 450-1539 | jskipper@lcr.org |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| CMD-193 | Drug | CMD-193 was administered as an IV infusion over 60 (± 5) minutes. |
|
| Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
| Mean Volume of Central Compartment of 111-In-CMD-193 | 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. | Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
| Mean Total Serum Clearance of 111-In-CMD-193 | 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. | Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
| Mean Area Under the Serum Concentration Curve Extrapolated to Infinite Time for 111-In-CMD-193 | 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. | Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
| Up to 4 months |
| Number of Subjects With Best Metabolic Tumor Response by European Organisation for Research and Treatment of Cancer (EORTC) Guidelines at End of Study | 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). | Up to 4 months |
| Ludwig Institute Tumor Targeting Program, Austin Health |
| Heidelberg (Melbourne) |
| Victoria |
| 3084 |
| Australia |
| Background |
| Young H, Baum R, Cremerius U, Herholz K, Hoekstra O, Lammertsma AA, Pruim J, Price P. Measurement of clinical and subclinical tumour response using [18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations. European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Eur J Cancer. 1999 Dec;35(13):1773-82. doi: 10.1016/s0959-8049(99)00229-4. |
| 19825951 | Result | Herbertson RA, Tebbutt NC, Lee FT, MacFarlane DJ, Chappell B, Micallef N, Lee ST, Saunder T, Hopkins W, Smyth FE, Wyld DK, Bellen J, Sonnichsen DS, Brechbiel MW, Murone C, Scott AM. Phase I biodistribution and pharmacokinetic study of Lewis Y-targeting immunoconjugate CMD-193 in patients with advanced epithelial cancers. Clin Cancer Res. 2009 Nov 1;15(21):6709-15. doi: 10.1158/1078-0432.CCR-09-0536. Epub 2009 Oct 13. |
Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Primary tumor | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | PS 0 = Fully active, able to carry on all pre-disease performance without restriction; PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; PS 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; PS 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; PS 5 = Dead | Count of Participants | Participants |
|
Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m^2 IV on Day 1 of subsequent 21-day cycles.
| OG001 | Cohort 2 (2.6 mg/m^2) | Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles. |
|
|
| Primary | Mean Effective Half-life of 111-In-CMD-193 Based on Gamma Camera Images | 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. | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | Posted | Mean | Standard Deviation | hours | Up to 8 days |
|
|
|
| Primary | Mean Serum Half-lives of 111-In-CMD-193 | 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. | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | Posted | Mean | Standard Deviation | hours | Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
|
|
|
| Primary | Mean Volume of Central Compartment of 111-In-CMD-193 | 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. | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | Posted | Mean | Standard Deviation | mL | Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
|
|
|
| Primary | Mean Total Serum Clearance of 111-In-CMD-193 | 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. | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | Posted | Mean | Standard Deviation | mL/hr | Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
|
|
|
| Primary | Mean Area Under the Serum Concentration Curve Extrapolated to Infinite Time for 111-In-CMD-193 | 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. | All subjects who received a single infusion of 111-In-CMD-193 on Day 1. | Posted | Mean | Standard Deviation | μg*hr/mL | Approximately 15 days (i.e., Days 1, 3, 8, and 15) |
|
|
|
| Secondary | Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) | 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. | All subjects who received at least 1 dose of study treatment and completed protocol procedures through at least 21 days following their first cycle. | Posted | Count of Participants | Participants | Up to 4 months |
|
|
|
| Secondary | Number of Subjects With Best Metabolic Tumor Response by European Organisation for Research and Treatment of Cancer (EORTC) Guidelines at End of Study | 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). | All subjects who received at least 1 dose of study treatment and completed protocol procedures through at least 21 days following their first cycle. | Posted | Count of Participants | Participants | Up to 4 months |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Cohort 2 (2.6 mg/m^2) | Subjects received 111-In-CMD-193 (3-7 mCi) IV on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m^2 IV on Day 1 of subsequent 21-day cycles. | 1 | 3 | 1 | 3 | 3 | 3 |
| Malignant pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Gastroesophageal reflux | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Ankle oedema | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Flushing | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Lethargy | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vasovagal symptoms | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Right upper quadrant pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cold symptoms | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Sebaceous cyst | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Flu-like symptoms | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Oedematous feet | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pitting oedema | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Lactate dehydrogenase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Proteins serum plasma low | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Discolouration skin | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal crampy pains | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Tenderness epigastric | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Head cold | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Pain in hip | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Weakness in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Paresthesia of fingers | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal bloating | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal noises | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Chloride low | Investigations | MedDRA (9.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
|
| Crackles lung | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (9.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
|
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
|
Not provided
| Progressive metabolic disease |
|