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Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

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ClinicalTrials.gov Identifier: NCT03318939
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:
This is a Phase 2, open-label, multicenter study to evaluate the efficacy and the safety/tolerability of poziotinib in four patient cohorts for up to 174 previously treated NSCLC patients with any systemic therapy (87 patients with EGFR exon 20 insertion mutations and 87 patients with HER2 exon 20 insertion mutations) and up to 140 treatment-naive NSCLC patients (70 patients with EGFR exon 20 insertion mutations and 70 patients with HER2 exon 20 insertion mutations).

Condition or disease Intervention/treatment Phase
NSCLC Drug: Poziotinib Phase 2

Detailed Description:

The Screening period (Day -30 to Day -1) lasts up to approximately 30 days prior to Cycle 1, Day 1. Patients must meet all Inclusion/Exclusion Criteria to participate in the study. Eligible patients will provide written Informed Consent prior to undergoing any study procedures.

Each treatment cycle is 28 calendar days in duration. There will be four patient cohorts and eligible patients will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status and prior treatment status:

  • Cohort 1: Previously treated patients with EGFR exon 20 insertion mutation positive NSCLC
  • Cohort 2: Previously treated patients with HER2 exon 20 insertion mutation positive NSCLC
  • Cohort 3: Treatment naïve patients with EGFR exon 20 insertion mutation positive NSCLC
  • Cohort 4: Treatment naïve patients with HER2 exon 20 insertion mutation positive NSCLC

Toxicity will be assessed based on the grade of the adverse events using CTCAE version 4.03.

All treatments will be taken orally, once daily (QD) at approximately the same time each morning. On Day 1 of each 28-day cycle, the patient's absolute neutrophil count (ANC) must be ≥1.5×10^9/L and platelet count must be ≥100×10^9/L before administering poziotinib. All patients will be treated until disease progression, death, intolerable adverse events, or other protocol-specified reasons for patient withdrawal.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Each treatment cycle is 28 calendar days in duration. There will be four patient cohorts and eligible patients will be enrolled into each cohort in parallel based on EGFR or HER2 exon 20 mutation status and prior treatment status:

  • Cohort 1: Previously treated patients with EGFR exon 20 insertion mutant positive NSCLC
  • Cohort 2: Previously treated patients with HER2 exon 20 insertion mutant positive NSCLC
  • Cohort 3: Treatment naive patients with EGFR exon 20 insertion mutant positive NSCLC
  • Cohort 4: Treatment naive patients with HER2 exon 20 insertion mutant positive NSCLC
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Poziotinib
  • Cohort 1: Previously treated patients with EGFR exon 20 insertion mutant positive NSCLC
  • Cohort 2: Previously treated patients with HER2 exon 20 insertion mutant positive NSCLC
  • Cohort 3: Treatment naive patients with EGFR exon 20 insertion-mutant positive NSCLC
  • Cohort 4: Treatment naive patients with HER2 exon 20 insertion mutant positive NSCLC
Drug: Poziotinib
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 24 months ]
    The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of poziotinib to the end of study.


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: 24 months ]
    The proportion of subjects who achieve CR, PR, and Stable Disease (SD) by the best response from the first dose of poziotinib to the end of study.

  2. Duration of Response (DoR) [ Time Frame: 24 months ]
    Number of days from the date that measurement criteria are first met for CR or PR (whichever status is recorded first) until the first subsequent date that progressive disease or death is documented.


Other Outcome Measures:
  1. Progression-free Survival (PFS) - Exploratory [ Time Frame: 24 months ]
    Number of days from the treatment start date to the date of documented disease progression or death due to any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Key Inclusion Criteria:

  • Patient must be willing and capable of giving written Informed Consent, adhering to dosing and visit schedules, and meeting all study requirements
  • Patient has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to treatment with curative intent
  • Prior treatment status:

    • Cohorts 1 and 2: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
    • Cohorts 3 and 4: Patient is treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with poziotinib as determined by the Investigator. Adjuvant/neo-adjuvant therapies (chemotherapy, radiotherapy, or investigational agents) are permissible as long as they end at least 15 days prior to study entry.
  • Specific mutations:

    • Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
    • Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
  • Patient has adequate organ function at Baseline

Key Exclusion Criteria:

  • Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible.
  • Patient has had radiotherapy (intention for cure) or surgery (other than surgical placement for vascular access and minimally invasive procedures including some biopsy procedures) within 2 weeks prior to start of study treatment with poziotinib
  • Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully treated and stable early stage prostate cancer or carcinoma in situ of the cervix or breast without need of treatment
  • Patient is pregnant or breast-feeding

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): NCT03318939


Contacts
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Contact: Sanjay Mourya (949)743-9322 spi-poz-202@sppirx.com
Contact: Bill Paxton, MD spi-poz-202@sppirx.com

Locations
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United States, California
Pacific Shores Medical Group Recruiting
Long Beach, California, United States, 90813
United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Texas
Texas Oncology- Austin Recruiting
Austin, Texas, United States, 78745
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc

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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03318939     History of Changes
Other Study ID Numbers: SPI-POZ-202
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spectrum Pharmaceuticals, Inc:
EGFR
HER2
Exon 20 insertion mutation