Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 12
Summary
- Conditions
- HER2 Negative Metastatic Breast Cancer
- Recurrent Ovarian Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03430518
- Collaborators
- AstraZeneca
- Eisai Inc.
- Investigators
- Principal Investigator: Amy Tiersten, MD Icahn School of Medicine at Mount Sinai
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