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Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss — COPAN-ORL06  

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

Official title:
Phase ib/II Trial of Copanlisib, a Selective PI3K Inhibitor, in Combination With Cetuximab in Patients With Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss.

Clinical Trial Summary

The study consists of two distinct and sequential parts: - A Phase Ib aimed at determining the MTD (Maximum Tolerated Dose) of the combination (copanlisib/cetuximab) and the RP2D - A Phase II aimed at evaluating the efficacy of the combination at the RP2D (Recommended Phase 2 Dose) All patients will be treated with the Copanlisib, a selective PI3KCA inhibitor, in association with Cetuximab.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02822482
Study type Interventional
Source UNICANCER
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date June 2016
Completion date October 9, 2019
View Details
See also
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