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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
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This was a Phase I/II, single-center, dose-escalation study. 177-Lutetium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-cG250 (177-Lu-DOTA-cG250) was administered at a starting dose of 30 mCi/m^2 of 177-Lu (fixed dose of 10 mg cG250) and escalated in increments of 10 mCi/m^2 of 177-Lu in sequentially enrolled cohorts according to a standard 3 + 3 design until determination of the maximum tolerated dose (MTD). The primary objectives were to determine the safety, targeting, and dosimetry of 177-Lu-DOTA-cG250 in subjects with advanced renal cell carcinoma. The secondary objective was measurement of tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
Prior to administration of 177-Lu-DOTA-cG250, subjects received 5 mCi/10 mg of the 111-Indium-DOTA-cG250 (111-In-DOTA-cG250) antibody (an imaging dose). Whole body and blood measurements of radioactivity were obtained on at least 3 occasions for 1 week to determine targeting and dosimetry. If at least one known and evaluable metastatic lesion was visualized with 111-In-DOTA-cG250, a single dose of therapeutic 177-Lu-DOTA-cG250 was administered the following week. In the absence of disease progression and after recovery from toxicity, subjects may have been retreated no sooner than 12 weeks after the previous treatment with a dose of no more than 75% of the previous dose, for a total of not more than 3 treatments. Only subjects with normal pharmacokinetics on the diagnostic 111-In-DOTA-cG250 study (indicative of human anti-chimeric antibody [HACA] negativity) were eligible for re-treatment.
Subjects in the initial cohort were enrolled sequentially to receive 30 mCi/m^2 of 177-Lu-DOTA-cG250 (fixed dose of 10 mg cG250). In the absence of a dose-limiting toxicity, the dose was escalated in each subsequent cohort in 10 mCi/m^2 increments of 177-Lu. At least 3 subjects per dose level were followed for up to 12 weeks with imaging, biochemical, and hematologic tests. Safety was monitored continuously throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250 | Experimental | Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu. |
|
| Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250 | Experimental | Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu. |
|
| Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250 | Experimental | Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu. |
|
| Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250 | Experimental | Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu. |
|
| Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250 | Experimental | Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 111-In-DOTA-cG250 | Drug | On Day 1, each subject received a single intravenous (IV) infusion of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events | Toxicity was graded in accordance with the NCI CTCAE version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment. | Up to 1 year |
| Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1 | Subjects were monitored for AEs for ≥ 8 weeks after the last infusion of 177-Lu-DOTA-cG250 before dose escalation could be implemented. Toxicity was graded in accordance with the NCI CTCAE version 3.0. DLT was defined as the following treatment-related events: ≥ Grade 3 non-hematologic toxicity; ≥ Grade 4 hematologic toxicity (platelets < 25 × 10^9/L or leukocytes < 1.0 × 10^9/L) that persisted for > 4 weeks except anemia; thrombocytopenia < 10 × 10^9/L; clinically relevant myelotoxicity that required hospitalization and/or blood product transfusion (e.g., uncontrolled bleeding, infections that had to be treated clinically). | 12 weeks |
| Radiation Absorbed Doses by Organ for 177-Lu-cG250 | After each 177-Lu-cG250 administration, 3 whole-body scintigrams were acquired (directly after injection and 2-4 days and 5-7 days post-injection) and blood samples were drawn at 5, 30, 60, and 120 min, 2-4 days, and 5-7 days post-infusion. Estimated radiation absorbed doses were calculated according to the Medical Internal Radiation Dose scheme, which permits estimation of the factors required to calculate dose to one organ attributable to a source in another organ. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Best Overall Tumor Response | Tumor responses were evaluated using computed tomography and categorized according to RECIST v1.0 at baseline and at the end of every cycle (every 12 weeks) or after recovery from toxicity. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of 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:
Subjects with proven advanced and progressive renal cell carcinoma (RCC) of the clear cell type.
At least one evaluable lesion < 5 cm.
Karnofsky performance status ≥ 70%.
Laboratory values obtained < 14 days prior to registration:
Negative pregnancy test for women of childbearing potential (urine or serum).
Age over 18 years.
Ability to provide written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W.J.G. Oyen, MD | Department of Nuclear Medicine, University Medical Center Nijmegen | Principal Investigator |
| P.F.A. Mulders, MD | Department of Urology, University Medical Center Nijmegen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Nijmegen | Nijmegen | 6500HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22980441 | Result | Stillebroer AB, Boerman OC, Desar IM, Boers-Sonderen MJ, van Herpen CM, Langenhuijsen JF, Smith-Jones PM, Oosterwijk E, Oyen WJ, Mulders PF. Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma. Eur Urol. 2013 Sep;64(3):478-85. doi: 10.1016/j.eururo.2012.08.024. Epub 2012 Aug 21. | |
| 22159179 |
| Label | URL |
|---|---|
| Stillebroer et al. J Nucl Med 2012; 53(1):82-89 | View source |
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Data have been published
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu. |
| FG001 | Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu. |
| FG002 | Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu. |
| FG003 | Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu. |
| FG004 | Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu. |
| FG005 | Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Treatment-emergent Adverse Events | Toxicity was graded in accordance with the NCI CTCAE version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 4 weeks after the last dose of study treatment. | The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250. | Posted | Number | participants | Up to 1 year |
|
All AEs occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 1 year for each subject.
AE documentation included onset/resolution dates, severity using NCI CTCAE (v3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.
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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, 30 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Skipper PhD | Ludwig Institute for Cancer Research | 12124501539 | jskipper@lcr.org |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250 | Experimental | Subjects received an initial single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu. |
|
|
| 177-Lu-DOTA-cG250 | Drug | On Day 8, 9, or 10, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m^2 in the initial cohort. |
|
|
| Up to 9 months |
| Result |
| Stillebroer AB, Zegers CM, Boerman OC, Oosterwijk E, Mulders PF, O'Donoghue JA, Visser EP, Oyen WJ. Dosimetric analysis of 177Lu-cG250 radioimmunotherapy in renal cell carcinoma patients: correlation with myelotoxicity and pretherapeutic absorbed dose predictions based on 111In-cG250 imaging. J Nucl Med. 2012 Jan;53(1):82-9. doi: 10.2967/jnumed.111.094896. Epub 2011 Dec 12. |
| Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250 |
111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu. |
| BG002 | Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu. |
| BG003 | Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu. |
| BG004 | Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu. |
| BG005 | Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250 |
111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu. |
| OG002 | Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu. |
| OG003 | Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu. |
| OG004 | Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu. |
| OG005 | Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu. |
|
|
| Primary | Number of Subjects With Dose-limiting Toxicity (DLT) During Cycle 1 | Subjects were monitored for AEs for ≥ 8 weeks after the last infusion of 177-Lu-DOTA-cG250 before dose escalation could be implemented. Toxicity was graded in accordance with the NCI CTCAE version 3.0. DLT was defined as the following treatment-related events: ≥ Grade 3 non-hematologic toxicity; ≥ Grade 4 hematologic toxicity (platelets < 25 × 10^9/L or leukocytes < 1.0 × 10^9/L) that persisted for > 4 weeks except anemia; thrombocytopenia < 10 × 10^9/L; clinically relevant myelotoxicity that required hospitalization and/or blood product transfusion (e.g., uncontrolled bleeding, infections that had to be treated clinically). | The Safety Analysis Set comprises all subjects who received at least 1 dose of 111-In-DOTA-cG250 or 177-Lu-DOTA-cG250. | Posted | Number | participants | 12 weeks |
|
|
|
|
| Primary | Radiation Absorbed Doses by Organ for 177-Lu-cG250 | After each 177-Lu-cG250 administration, 3 whole-body scintigrams were acquired (directly after injection and 2-4 days and 5-7 days post-injection) and blood samples were drawn at 5, 30, 60, and 120 min, 2-4 days, and 5-7 days post-infusion. Estimated radiation absorbed doses were calculated according to the Medical Internal Radiation Dose scheme, which permits estimation of the factors required to calculate dose to one organ attributable to a source in another organ. | The Dosimetry Evaluable Analysis Set comprises all subjects who received at least 1 dose of 177-Lu-cG250. | Posted | Mean | Standard Deviation | mGy/MBq | 12 weeks |
|
|
|
| Secondary | Number of Subjects With Best Overall Tumor Response | Tumor responses were evaluated using computed tomography and categorized according to RECIST v1.0 at baseline and at the end of every cycle (every 12 weeks) or after recovery from toxicity. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions [no evidence of 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. | The Evaluable Analysis Set comprises subjects who completed Cycle 1 (ie, received both 111-In-DOTA-cG250 and 177-Lu-DOTA-cG250) and had at least 1 post-baseline response assessment. The Evaluable Analysis Set includes 23 subjects who completed Cycle 1, 12 subjects who completed Cycle 2, and 4 subjects who completed Cycle 3. | Posted | Number | participants | Up to 9 months |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu. | 2 | 3 | 3 | 3 |
| EG002 | Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu. | 1 | 6 | 6 | 6 |
| EG003 | Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu. | 0 | 3 | 3 | 3 |
| EG004 | Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu. | 1 | 3 | 2 | 3 |
| EG005 | Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250 | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu. | 2 | 8 | 6 | 8 |
| EG006 | Total | 111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In. 177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu. | 6 | 26 | 23 | 26 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| Grade 4 Thrombocytopenia |
|
| Grade 4 Leukopenia |
|
| Grade 4 Neutropenia |
|
| Grade 3 Epistaxis |
|
| Grade 3 Fatigue |
|
| Grade 3 Hematoma |
|
| Title | Measurements |
|---|---|
|
| Red Marrow (Image-based) |
|
| Red Marrow (Blood-based) |
|
| Kidney |
|
| Lungs |
|
| Testes |
|
| Metastases |
|
| Cycle 1: Progressive Disease |
|
| Cycle 2: Partial Response |
|
| Cycle 2: Stable Disease |
|
| Cycle 2: Progressive Disease |
|
| Cycle 3: Stable Disease |
|
| Cycle 3: Progressive Disease |
|