A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

NCT03429101 | Terminated Phase 1 FDA Drug

• 1 other identifier: SPI-POZ-101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.

Conditions

Breast Cancer

Keywords

Poziotinib; HER2 Positive; T-DM1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Evaluate the Objective Response Rate (ORR) in patients treated with daily poziotinib in combination with T-DM1 (every 3 weeks) in women with advanced or metastatic HER2 positive breast cancer.

  3 Years

Secondary Outcomes (2)

• Disease Control Rate (DCR)

  27 weeks

• Progression-free Survival (PFS)

  3 years

Study Arms (1)

Poziotinib

EXPERIMENTAL

* Part 1: Dose Finding The MTD/MAD of poziotinib in combination with the standard dose of T-DM1 will be determined by using a "3+3" design. At least 3 patients may be enrolled in each cohort before a decision is made to proceed to the next cohort. * Part 2: MTD/MAD Expansion An additional 10 patients will be treated at the dose identified during Part 1 to further evaluate the combination at the MTD or the MAD.

Drug: Poziotinib; Drug: T-DM1

Interventions

Poziotinib DRUG

Poziotinib is a tablet for oral administration.

Poziotinib

T-DM1 DRUG

T-DM1 (ado-trastuzumab emtansine) is a HER2-targeted therapy for I.V. administration.

Also known as: ado-trastuzumab emtansine

Poziotinib

Eligibility Criteria

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

You may qualify if:

• Patient must be female, at least 18 years of age, but not older than 90 years, with advanced or metastatic HER2+ breast cancer and a life expectancy of more than 6 months
• Patient must have confirmed HER2 overexpression or gene-amplified tumor via immunohistochemistry \[IHC\] with IHC 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization \[FISH\]+ or \[ISH\]+
• Patients must have had at least 1 line of anti-HER2 directed therapy either in the metastatic or early-stage disease setting
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if:

• Patient has had previous treatment with poziotinib.
• Patient has received anticancer chemotherapy, TKIs, biologics, immunotherapy, radiotherapy, or investigational treatment within 15 days. (There is no washout for hormonal therapy for breast cancer).
• Patient has a life expectancy less than 3 years due to other malignancies.
• Patient is pregnant or breast-feeding.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (2)

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

Los Angeles Hematology Oncology Medical Group

Glendale, California, 91204, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

HM781-36B; Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Part 1: Dose Finding To determine the MTD/MAD of poziotinib in combination with the standard dose of T-DM1 by using a "3+3" design. At least 3 patients may be enrolled in each cohort before a decision is made to proceed to the next cohort. * Part 2: MTD/MAD Expansion An additional 10 patients will be treated at the dose identified during Part 1 of the study to further evaluate the safety and efficacy.

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 12, 2018
• Study Start: July 13, 2018
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

US (2)