NCT03430518

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Amy Tiersten · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• HER2-Negative Metastatic Breast Cancer
• Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	1.12g given IV on day 1 every 21 day cycle
DRUG	Eribulin	1.1 mg/m2 IV on day 8 of every 21 day cycle in the first 3 patients, then increased to 1.4mg/m2 IV on day 1 and day 8 of every 21 day cycle. If significant toxicity occurs in patients given the 1.1mg/m2 IV dose, then subsequent patients with receive eribulin 0.7mg/m2 IV on day 1 and day 8 of every 21 day cycle.

Timeline

• Start date: 2018-05-17
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2018-02-13
• Last updated: 2020-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study