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Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)

NCT02753595 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-07-13

Study results available
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Summary

The primary objective for the study is as follows:

For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast cancer (MBC) previously treated with up to two lines of systemic anticancer therapy in the metastatic setting.

For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC previously treated with up to 2 lines of systemic anticancer therapy in the metastatic setting.

Conditions

Interventions

DRUG

Eribulin mesylate

Eribulin mesylate will be administered at 1.4 mg/m\^2 or 1.1 mg/m\^2 as intravenous (IV) infusion on Day 1 and 8 of 21-day cycle

DRUG

Eribulin mesylate

Eribulin mesylate will be administered at 1.4 mg/m\^2 or 1.1 mg/m\^2, depending on RP2D, as IV infusion on Day 1 and 8 of each 21-day cycle

DRUG

Eribulin mesylate

Eribulin mesylate will be administered at 1.4 mg/m\^2 as IV infusion on Day 1 and 8 of 21-day cycle

OTHER

Biologic: PEGylated recombinant human hyaluronidase (PEGPH20)

PEGPH20 will be administered at 3.0 mcg/kg or 1.6 mcg/kg as IV infusion on Day -1 and 7 of 21-day cycle

OTHER

Biologic: PEGylated recombinant human hyaluronidase

PEGPH20 will be administered at 3.0 mcg/kg or 1.6 mcg/kg, depending on RP2D, as IV infusion on Day -1 and 7 of each 21-day cycle

Sponsors & Collaborators

  • Halozyme Therapeutics

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-13
Primary Completion
2019-08-16
Completion
2019-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02753595 on ClinicalTrials.gov