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Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer

Recurrent Ovarian Cancer Clinical Trial

Official title:
A Phase Ib Study Evaluating the Safety and Tolerability of Durvalumab (MEDI4736) (Anti-PDL1) in Combination With Eribulin in Patients With HER2-Negative Metastatic Breast Cancer and Recurrent Ovarian Cancer

Clinical Trial Summary

This study will evaluate the recommended Phase 2 combination dose (RP2D) of eribulin with durvalumab.

Clinical Trial Description

STUDY SUMMARY

Study Duration: Accrual will take place over the course of 16 months. Patients will be treated until unacceptable toxicity or disease progression (expected on average for 6 months) and then followed for one year thereafter.

Objectives: Phase I: To determine the the recommended phase II dose of eribulin in combination with Durvalumab

This study will evaluate the recommended Phase 2 combination dose (RP2D) of eribulin with durvalumab. If two or more out of 6 patients experience a dose limiting toxicity (DLT) at dose level I or II, the dose level below that level will be considered the RP2D. If all 3 patients enter dose level-I and experience DLT, the study will be terminated. If the highest level has been reached and < 33% of patients have experienced DLT, that will be considered the RP2D. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03430518
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase Phase 1
Start date May 17, 2018
Completion date February 10, 2020
View Details
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