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

Part of paid clinical trials in New York, New York.

Sponsor
Amy Tiersten
Study ID
NCT03430518
Phase
PHASE1
Status
Completed

Conditions

  • HER2-Negative Metastatic Breast Cancer
  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    1.12g given IV on day 1 every 21 day cycle
  • Eribulin — DRUG
    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.

Study Details

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

Key Dates

First listed
Feb 13, 2018
Start date
May 17, 2018
Status verified
Aug 2020
Primary completion
Feb 10, 2020
Completion
Feb 10, 2020

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Her2-negative Metastatic Breast Ca and Recurrent Ovarian Ca
    Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian cancer

Primary Outcome Measure

The dose-limiting toxicity (DLT) rate [ Time Frame: 42 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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