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

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-

Find similar trials in New York, NY

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

Related Studies