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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

NCT02822482 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-03-29

No results posted yet for this study

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.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

Copanlisib

Copanlisib will be given at Day 1, Day 8 and Day 15 (1 cycle = 28 days), administered intravenously over 60 minutes, in association with Cetuximab.

DRUG

Cetuximab

Cetuximab will be given weekly at Day 1, Day 8, Day 15 and Day 22 (1 cycle = 28 days), administered intravenously over 120 minutes (Cycle 1 Day 1) or 60 minutes (subsequent infusions), in association with Copanlisib.

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-10-09
Completion
2019-10-09

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02822482 on ClinicalTrials.gov