Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer

NCT02659514 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SPI-POZ-201
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 35

Brief Summary

The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens.

Conditions

Breast Cancer

Keywords

Poziotinib; Metastatic Breast Cancer; HER2-positive; Pan-HER inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) among participants in the Evaluable Population assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR was based on investigator assessed BOR. Per RECIST v1.1 for target lesions, CR was disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis \<10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (PD) (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).

  Up to 24 months

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Up to 24 Months

• Disease Control Rate (DCR)

  Up to 24 months

• Time to Progression (TTP)

  Up to 24 months

• Duration of Response (DoR)

  Up to 24 months

• Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

  From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (Up to approximately 25 months)

Study Arms (2)

Cohort 1: Poziotinib 24 mg

EXPERIMENTAL

Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first.

Drug: Poziotinib

Cohort 2: Poziotinib 16 mg

EXPERIMENTAL

Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.

Drug: Poziotinib

Interventions

Poziotinib DRUG

8 mg oral tablets, administered QD.

Also known as: HM781-36B

Cohort 1: Poziotinib 24 mg; Cohort 2: Poziotinib 16 mg

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed primary breast cancer with metastatic lesions.
• Confirmed HER2 overexpression or gene-amplified tumor
• At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine
• Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
• Participant is at least 18, and ≤90 years of age.
• Adequate hematologic, hepatic, and renal function
• Eastern Cooperative Oncology Group (ECOG) performance status \<= 2

You may not qualify if:

• Previous treatment with poziotinib prior to study participation
• Brain metastases that are symptomatic or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 15 days of enrollment.
• Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or investigational treatment within 15 days, except for hormone therapy, palliative therapy, or supportive therapy.
• History of congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
• Cardiac ejection fraction \<50%
• History of other malignancies within the last 5 years
• Participant is pregnant or breast-feeding.
• Unable to take drugs orally

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (35)

Clearview Cancer Center

Huntsville, Alabama, 35805, United States

Location

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

Marin Cancer Care, Inc

Greenbrae, California, 94904, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

PacificShores Medical Group

Long Beach, California, 90813, United States

Location

Valley Medical Oncology Consultants

Pleasanton, California, 94588, United States

Location

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

AMPM Research Clinic

Miami Gardens, Florida, 33169, United States

Location

FL Cancer Research Institute

Plantation, Florida, 33324, United States

Location

Bond Clinic, P.A.

Winter Haven, Florida, 33880, United States

Location

Triple Army Medical Cente

Honolulu, Hawaii, 96859, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

The University of Kansas Cancer Center and Medical Pavilion

Westwood, Kansas, 66205, United States

Location

Hattiesburg Clinic Hematology Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

North Shore Hematology Oncology Associates

East Setauket, New York, 11733, United States

Location

Hudson Valley Hematology Oncology Associates

Poughkeepsie, New York, 12601, United States

Location

White Plain Hospital

White Plains, New York, 10601, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Cancer Specialists & Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Carolina Blood and Cancer Care Associates PA

Rock Hill, South Carolina, 29732, United States

Location

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

Location

SAMMC - Hem/Onc Clinic

Houston, Texas, 78234, United States

Location

Texas Oncology-McAllen

McAllen, Texas, 78503, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Providence Regional Cancer System

Lacey, Washington, 98503, United States

Location

Medical Oncology Associates, PS

Spokane, Washington, 99208, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

HM781-36B

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Shanta Chawla
• Organization: Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

shanta.chawla@sppirx.com

9497886700

Study Officials

• Shanta Chawla, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 20, 2016
• Study Start: February 22, 2016
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: March 11, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)