A Study to Evaluate the Safety and Antitumor Activity in Subjects with Advanced Solid Tumors
Study identifier:CD-ON-MEDI3617-1043
ClinicalTrials.gov identifier:NCT01248949
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617 as a Single-Agent or in Combination Therapy in Adult Subjects with Advanced Solid Tumors
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
MEDI3617, Bevacizumab, Paclitaxel, Carboplatin
Sex
All
Actual Enrollment
162
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 01 Oct 2010
Primary Completion Date: 01 Jul 2015
Study Completion Date: 01 Oct 2015
Study design
Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2017 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI3617 SINGLE AGENT TOTAL Participants will receive MEDI3617 via intravenous (IV) infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days. | Drug: MEDI3617 Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. |
| Experimental: MEDI3617 + BEVACIZUMAB Q3W ESCALATION Participants will receive MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days. | Drug: MEDI3617 Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Drug: Bevacizumab Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. |
| Experimental: MEDI3617 + BEVACIZUMAB Q2W TOTAL Participants will receive MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days. | Drug: MEDI3617 Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Drug: Bevacizumab Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. |
| Experimental: MEDI3617 + PACLITAXEL TOTAL Participants will receive MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days. | Drug: MEDI3617 Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Drug: Paclitaxel Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. |
| Experimental: MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL Participants will receive MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days. | Drug: MEDI3617 Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Drug: Paclitaxel Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Drug: Carboplatin Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. |
Contacts
Investigators
Principal Investigator
MedImmune, LLC
MedImmune, LLC
