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Last Updated: November 20, 2019

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CLINICAL TRIALS PROFILE FOR PATRITUMAB

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Clinical Trials for Patritumab

Trial ID Title Status Sponsor Phase Summary
NCT01042379 I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer Recruiting QuantumLeap Healthcare Collaborative Phase 2 The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
NCT01957280 Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287) Completed Daiichi Sankyo Inc. Phase 1 The purpose of this study is to assess the PK, safety, and tolerability of patritumab produced by a new manufacturing process (denoted as "Process 2 patritumab"). The data from this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow for any dose adjustments, if needed, and to bridge data from studies previously conducted with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be comparable to those of Process 1 patritumab.
NCT02134015 Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung) Active, not recruiting Parexel Phase 3 1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin. 2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
NCT02134015 Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung) Active, not recruiting Daiichi Sankyo Inc. Phase 3 1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin. 2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Patritumab

Condition Name

Condition Name for
Intervention Trials
Non-small Cell Lung Cancer 1
Neoplasms by Site 1
Lung Cancer 1
Head and Neck Neoplasms 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Head and Neck Neoplasms 2
Carcinoma, Squamous Cell 2
Lung Neoplasms 1
Neoplasms, Squamous Cell 1
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Clinical Trial Locations for Patritumab

Trials by Country

Trials by Country for
Location Trials
United States 35
Germany 8
Poland 6
United Kingdom 5
Hungary 5
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Trials by US State

Trials by US State for
Location Trials
Texas 3
Florida 3
Oregon 2
Minnesota 2
Illinois 2
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Clinical Trial Progress for Patritumab

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 2
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Patritumab

Sponsor Name

Sponsor Name for
Sponsor Trials
Daiichi Sankyo Inc. 4
Parexel 1
QuantumLeap Healthcare Collaborative 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
Other 1
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