A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects with Advanced Tumors. - MEDI-575
Study identifier:MI-CP187
ClinicalTrials.gov identifier:NCT00816400
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-575, a Fully Human Monoclonal Antibody Directed Against Platelet-derived Growth Factor Receptor Alpha (PDGFRα), 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-575
Sex
All
Actual Enrollment
49
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 02 Mar 2009
Primary Completion Date: 19 Jan 2012
Study Completion Date: 19 Jan 2012
Study design
Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1) Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2) MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3) MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4) MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5) MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6) MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7) MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 9.0 mg/kg QWk Expansion Phase MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
| Experimental: MEDI-575, 25 mg/kg Q3Wk Expansion Phase MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred. | Drug: MEDI-575 MEDI-575 as an IV infusion |
