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

NCT03430518 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-08-05

No results posted yet for this study

Summary

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

Conditions

  • HER2-Negative Metastatic Breast Cancer
  • Recurrent Ovarian Cancer

Interventions

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Eisai Inc.

    collaborator INDUSTRY

  • Amy Tiersten

    lead OTHER

Principal Investigators

  • Amy Tiersten, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2020-02-10
Completion
2020-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03430518 on ClinicalTrials.gov