Study identifier:CD-ON-MEDI-573-1030
ClinicalTrials.gov identifier:NCT01446159
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)
Hormone-sensitive, HER-2 negative metastatic breast cancer
Phase 2
No
MEDI-573, Aromatase Inhibitor
Female
188
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2020 by MedImmune, LLC
MedImmune, LLC
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Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.
This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and a randomization phase (Phase 2).
Location
Location
Canton, OH, United States, 44718
Location
Lawrenceville, GA, United States, 30046
Location
Middletown, OH, United States, 45042
Location
Nashville, TN, United States, 37205
Location
Athens, GA, United States, 30607
Location
Bethesda, MD, United States, 20817
Location
Augusta, GA, United States, 30901
Location
St Petersburg, FL, United States, 33705
Arms | Assigned Interventions |
---|---|
Experimental: MEDI-573 10 mg/kg + AI Participants who will be enrolled in Phase 1b Cohort A of the study will receive intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: MEDI-573 Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
Experimental: MEDI-573 30 mg/kg + AI Participants who will be enrolled in Phase 1b Cohort B of the study will receive intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: MEDI-573 Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
Experimental: MEDI-573 45 mg/kg + AI Participants who will be enrolled in Phase 1b Cohort C and Phase 2 Arm 1 of the study will receive intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: MEDI-573 Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
Experimental: Aromatase Inhibitor Participants who will be enrolled in Phase 2 Arm 2 of the study will receive oral AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
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