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To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MEDI-522 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-522 | Drug | MEDI-522 will be administered at doses of 1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg. [As a 30 minute IV infusion initially as a single dose (single-dose treatment period) and 2 to 5 weeks later as weekly doses (multiple-dose treatment period) for up to 1 year.] |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose. | Study Day 1 up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Will be assessed using the variables of area under the concentration curve (AUC) which will be calculated by the trapezoidal rule, peak concentration (Cmax), time to peak concentration (Tmax), half life | 35 days after the first dose | |
| Measured pharmacokinetic parameters may be one of the factors used in determination of the Phase II regimen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luz Hammershaimb, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Villejuf | 94805 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C112567 | etaracizumab |
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| Appx. 5 days after the 4th weekly dose |
| Antitumor Activity: The antitumor activity of MEDI-522 in patients with refractory solid tumors will be assessed by calculating tumor response rate and time to disease progression. |