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Trial record 1 of 1 for:    PEGPH20 in combination with HALAVEN® (eribulin)
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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)

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ClinicalTrials.gov Identifier: NCT02753595
Recruitment Status : Active, not recruiting
First Posted : April 28, 2016
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Eisai Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Eribulin mesylate Other: Biologic: PEGylated recombinant human hyaluronidase (PEGPH20) Other: Biologic: PEGylated recombinant human hyaluronidase Phase 1 Phase 2

Detailed Description:

Phase 1b will occur in two parts:

Part 1: Run-in safety cohort(s) (dose levels 1, 0, and -1, as necessary) of 6 participants each will be conducted until the RP2D is determined. The purpose of the run-in safety cohort(s) is to study the safety of the 2-drug combination and determine a RP2D. Dose limiting toxicity (DLT) will be assessed in the first cycle to determine the RP2D of eribulin mesylate in combination with PEGPH20.

Part 2 (Phase 1b "Expansion Part"): A total of 12 additional participants will be enrolled at the RP2D determined in Part 1 (using Phase 1b criteria, i.e., participants previously treated with up to 2 lines of systemic anticancer therapy) in order to assess the safety profile of the combination and identify any potential safety signals and the incidence of thromboembolic events in this population.

In Phase 2, participants will be stratified by triple negative breast cancer (TNBC) status and randomized 1:1 to receive eribulin mesylate and PEGPH20 at the established RP2D level or eribulin mesylate alone at 1.4 milligrams per square meters (mg/m^2).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter, Phase 1b/2 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)
Actual Study Start Date : July 13, 2016
Estimated Primary Completion Date : May 9, 2019
Estimated Study Completion Date : May 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Eribulin mesylate plus PEGPH20 (Phase 1b)

Recommended Phase 2 dose (RP2D) will be assessed in the below dose levels:

  • RP2D level 1: PEGPH20 (3.0 microgram per killogram (μg/kg)) plus eribulin mesylate (1.4 milligrams per square meter (mg/m2)) or
  • RP2D level 0: PEGPH20 (1.6 μg/kg) plus eribulin mesylate (1.4 mg/m2) or
  • RP2D level -1: PEGPH20 (1.6 μg/kg) plus eribulin mesylate (1.1 mg/m2)

Dose level 1 can be selected as the RP2D if no more than 1 out of 6 participants has a DLT; otherwise, Dose level 0 will be assessed in a second cohort of 6 subjects and will be selected as the RP2D if no more than 1 subject has a DLT. Otherwise, Dose level - 1 will be assessed in a third cohort of 6 subjects. If no more than 1 of 6 subjects in this third cohort has a DLT, the Phase 2 part will proceed with dose level -1 as the RP2D. Otherwise, alternative doses will be explored prior to the start of Phase 2.

Drug: Eribulin mesylate
Eribulin mesylate will be administered at 1.4 mg/m2 or 1.1 mg/m2 as intravenous (IV) infusion on Day 1 and 8 of 21-day cycle
Other Name: E7389

Other: Biologic: PEGylated recombinant human hyaluronidase (PEGPH20)
PEGPH20 will be administered at 3.0 μg/kg or 1.6 μg/kg as IV infusion on Day -1 and 7 of 21-day cycle

Experimental: Eribulin mesylate plus PEGPH20 (Phase 2)
Participants will receive eribulin mesylate and PEGPH20 at the established RP2D level achieved in the Phase 1b.
Drug: Eribulin mesylate
Eribulin mesylate will be administered at 1.4 mg/m2 or 1.1 mg/m2, depending on RP2D, as IV infusion on Day 1 and 8 of each 21-day cycle
Other Name: E7389

Other: Biologic: PEGylated recombinant human hyaluronidase
PEGPH20 will be administered at 3.0 μg/kg or 1.6 μg/kg, depending on RP2D, as IV infusion on Day -1 and 7 of each 21-day cycle

Experimental: Eribulin mesylate (Phase 2)
Participants will receive eribulin mesylate at 1.4 mg/m2.
Drug: Eribulin mesylate
Eribulin mesylate will be administered at 1.4 mg/m2 as IV infusion on Day 1 and 8 of 21-day cycle
Other Name: E7389




Primary Outcome Measures :
  1. Recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) - Phase 1b [ Time Frame: up to 21 days (Cycle 1) ]
  2. Objective response rate (ORR) - Phase 2 [ Time Frame: Up to approximately 36 months ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) - Phase 2 [ Time Frame: Up to approximately 36 months ]
  2. Overall survival (OS) - Phase 2 [ Time Frame: Up to approximately 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Metastatic Her-2- breast cancer
  2. Up to 2 prior lines of cytotoxic or targeted anti-cancer therapy for metastatic disease
  3. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria

  1. Less than 6 months since prior neoadjuvant/adjuvant chemotherapy
  2. Known central nervous system (CNS) disease, except for those participants with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
  3. Previous history or current evidence of deep vein thrombosis (DVT), hereditary thrombophilic syndromes, pulmonary embolism (PE), cerebral vascular accident (CVA), transient ischemic attack (TIA), atrial fibrillation (AF), or active carotid artery disease requiring treatment
  4. Treatment with chemotherapy, hormonal, or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks preceding informed consent
  5. Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753595


Locations
United States, California
Whittier, California, United States, 90602
United States, Georgia
Atlanta, Georgia, United States, 30318
Newnan, Georgia, United States, 30265
United States, Indiana
Anderson, Indiana, United States, 46011
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, New York
Stony Brook, New York, United States, 11794
United States, Washington
Kennewick, Washington, United States, 99336
Sponsors and Collaborators
Eisai Inc.
Halozyme Therapeutics

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02753595     History of Changes
Other Study ID Numbers: E7389-M000-219
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Eisai Inc.:
PEGylated Recombinant Human Hyaluronidase
Eribulin Mesylate
E7389
PEGPH20
Human Epidermal Growth Factor Receptor 2-Negative
High-Hyaluronan

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Mitogens
Hyaluronic Acid
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents