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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI-573 | Experimental | MEDI-573 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-573 | Drug | MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies) | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3:day 1 (pre-dose) of every cycle; 30 days after the last dose; 3 months after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Bradley, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Matsuyama | Ehime | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25342141 | Derived | Iguchi H, Nishina T, Nogami N, Kozuki T, Yamagiwa Y, Yagawa K. Phase I dose-escalation study evaluating safety, tolerability and pharmacokinetics of MEDI-573, a dual IGF-I/II neutralizing antibody, in Japanese patients with advanced solid tumours. Invest New Drugs. 2015 Feb;33(1):194-200. doi: 10.1007/s10637-014-0170-x. Epub 2014 Oct 25. |
| Label | URL |
|---|---|
| Protocol Redacted | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000601324 | dusigitumab |
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| Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST) |
subjects who discontinue the study treatment for reasons other than disease progression or initiation of alternative anticancer therapy will undergo tumor assessment 3 months after the last dose of MEDI-573). The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. |
| Tumor assessment by RECIST 1.1 every 2 cycles |
| Pharmacokinetics, - Cmax | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. |
| Pharmacokinetics,- Cmax at steady state (Cmax, ss) | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. |
| Pharmacokinetics - time to maximum concentration (tmax) | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. |
| Pharmacokinetics, - terminal elimination rate constant (λz) | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. |
| Pharmacokinetics - (AUC(0-t)) | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. |
| Pharmacokinetics - total clearance and terminal phase (Vz) of MEDI-573 | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. |
| Pharmacodynamics: - Insulin-like growth factor (IGF)-I and IGF-II on circulating plasma levels of MEDI-573 | The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive. | For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose. |