A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects with Advanced Solid Tumors
Study identifier:MI-CP184
ClinicalTrials.gov identifier:NCT00816361
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Multicenter, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Subjects with Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists
Medical condition
cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI-573
Sex
All
Actual Enrollment
43
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 09 Mar 2009
Primary Completion Date: 11 Sept 2012
Study Completion Date: 11 Sept 2012
Study design
Allocation: N/A
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI-573 0.5 mg/Kg QWk Dose Escalation Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 1.5 mg/Kg QWk Dose Escalation Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 5 mg/Kg QWk Dose Escalation Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 10 mg/Kg QWk Dose Escalation Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 15 mg/Kg QWk Dose Escalation Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 30 mg/Kg Q3Wk Dose Escalation Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 45 mg/Kg Q3Wk Dose Escalation Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 5 mg/Kg QWk Dose Expansion Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
| Experimental: MEDI-573 15 mg/Kg QWk Dose Expansion Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. | Drug: MEDI-573 Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle. |
Contacts
Investigators
Principal Investigator
Susan Perez
MedImmune LLC
