Clinical Trial - NCT03318939

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

Recruiting

Sponsor: Spectrum Pharmaceuticals, Inc

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03318939

Protocol Info

Short Description: Phase 2 Poziotinib in NSCLC
Long Description: 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) (SPI-POZ-202)
MGH Status: Open
Sponsor: Spectrum Pharmaceuticals
Disease Program: Thoracic

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).
Condition Title Intervention Phase
NSCLC Poziotinib Phase 2
Study Type Interventional
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)

Primary Outcome Measures

Objective Response Rate (ORR) [Time Frame: 24 months] [Designated as safety issue: ]


Secondary Outcome Measures

Disease Control Rate (DCR) [Time Frame: 24 months] [Designated as safety issue: ]

Duration of Response (DoR) [Time Frame: 24 months] [Designated as safety issue: ]

Estimated Enrollment: 603
Study Start Date: October 2017
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: March 2023
Arms Assigned Interventions

Experimental:Poziotinib

Cohort 1: Previously treated patients with EGFR exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 2: Previously treated patients with HER2 exon 20 insertion mutant positive NSCLC (closed to enrollment) Cohort 3: Treatment naïve patients with EGFR exon 20 insertion-mutant positive NSCLC (fully enrolled) Cohort 4: Treatment naïve patients with HER2 exon 20 insertion mutant positive NSCLC Cohort 5: Patients who meet the criteria for enrollment in Cohort 1 to 4, but the enrollment in the respective cohort has been closed Cohort 6: Patients with acquired EGFR mutation who progressed while on treatment with first-line osimertinib Cohort 7: Patients with EGFR or HER2 activating mutations
Drug:Poziotinib
The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration. Cohorts 1-3: 16 mg QD Cohort 4: 8 mg BID Cohort 5: randomized to 8 mg BID or 6 mg BID or 10 mg QD Cohorts 6 and 7: 8 mg BID

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.
  • Cohort 5: Patients who meet the criteria for enrollment in Cohorts 1 to 4, but the enrollment in the respective cohort has been closed
  • Cohort 6: Patients with EGFR mutation-positive NSCLC who progressed while on treatment with first-line osimertinib
  • Cohort 7: Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC
  • Specific mutations:
  • Cohort 1 and 3: Documented EGFR exon 20 insertion mutation
  • Cohort 2 and 4: Documented HER2 exon 20 insertion mutation
  • Cohort 5: Documented EGFR or HER2 exon 20 insertion mutations
  • Cohort 6: Documented acquired EGFR mutation (tested after osimertinib progression)
  • Cohort 7: Documented EGFR or HER2 activating mutations
  • 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 (Cohorts 1 and 2).
  • Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment should not be used within 2 weeks or 5 half lives, whichever is longer; local radiation therapy for bone pain may be allowed
  • 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03318939

Locations

  • United States, Arizona
    • Mayo Clinic Hospital Phoenix, Arizona, United States, 85054
  • United States, California
    • Oncology Physician's Network Inc./OPN Healthcare Arcadia, California, United States, 91007
    • City of Hope Duarte, California, United States, 91010
    • UCSD -Moores Cancer Center La Jolla, California, United States, 92093
    • Pacific Shores Medical Group Long Beach, California, United States, 90813
    • Los Angeles Hematology Oncology Medical Group Los Angeles, California, United States, 90017
    • USC/Norris Comprehensive Cancer Center Los Angeles, California, United States, 90033
    • UC Davis Comprehensive Cancer Center Sacramento, California, United States, 95817
    • UCSF Helen Diller Comprehensive Cancer Center at Mt Zion San Francisco, California, United States, 94115
    • UCLA Hematology/Oncology Santa Monica, California, United States, 90404
    • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California, United States, 90502
    • Kaiser Permanente Medical Center Vallejo, California, United States, 94589
  • United States, Colorado
    • Rocky Mountain Cancer Center Boulder, Colorado, United States, 80303
  • United States, Connecticut
    • Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale New Haven, Connecticut, United States, 06510
  • United States, District of Columbia
    • Georgetown University Medical Center Washington, District of Columbia, United States, 20007
  • United States, Florida
    • Florida Hospital Orlando, Florida, United States, 32804
    • H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida, United States, 33612
    • The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A. Winter Haven, Florida, United States, 33881
  • United States, Georgia
    • University Cancer & Blood Center, LLC Athens, Georgia, United States, 30607
    • CTCA - Southeastern Regional Medical Center Newnan, Georgia, United States, 30265
  • United States, Illinois
    • CTCA - Midwestern Regional Medical Center Zion, Illinois, United States, 60099
  • United States, Louisiana
    • Highland Clinic, APMC Shreveport, Louisiana, United States, 71105
  • United States, Maryland
    • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • Karmanos Cancer Institute Detroit, Michigan, United States, 48201
  • United States, Minnesota
    • Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota, United States, 55404
    • Mayo Clinic Rochester, Minnesota, United States, 55905
  • United States, Mississippi
    • Hattiesburg Clinic Hematology/Oncology Hattiesburg, Mississippi, United States, 39401
  • United States, New York
    • Montefiore Einstein Medical Center for Cancer Care Bronx, New York, United States, 10461
    • North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists Bronx, New York, United States, 10469
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • NYU Langone Medical Center New York, New York, United States, 10016
    • North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists Port Jefferson Station, New York, United States, 11776
  • United States, North Carolina
    • Duke University Medical Center Durham, North Carolina, United States, 27710
  • United States, Ohio
    • Cleveland Clinic Cleveland, Ohio, United States, 44195
    • The Ohio State University Columbus, Ohio, United States, 43210
  • United States, Oklahoma
    • Oklahoma Cancer Specialists and Research Institute, LLC Tulsa, Oklahoma, United States, 74146
  • United States, Pennsylvania
    • CTCA - Eastern Regional Medical Center Philadelphia, Pennsylvania, United States, 19124
  • United States, Texas
    • Texas Oncology- Austin Austin, Texas, United States, 78745
    • MD Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Virginia
    • Virginia Cancer Specialists, PC Fairfax, Virginia, United States, 22031
  • United States, Washington
    • Seattle Cancer Care Alliance Seattle, Washington, United States, 98109
  • Belgium,
    • Saint Luc University Hospital Brussels, , Belgium,
    • University Hospitals Leuven Leuven, , Belgium,
    • Ambroise Pare University Hospital Center Mons, , Belgium,
    • General Hospital Delta Roeselare, , Belgium,
  • Canada, Alberta
    • Cross Cancer Institute Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, British Columbia
    • BC Cancer - Vancouver Vancouver, British Columbia, Canada, V5Z 4E6
  • Canada, Ontario
    • London Regional Cancer Program London, Ontario, Canada, N6A 5W9
    • Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • France,
    • Hopital Larrey, CHU Toulouse, Unité d'Oncologie des Voies Respiratoires Toulouse, , France,
    • Gustave Roussy Oncology Institute, Department of Medical Oncology Villejuif, , France,
  • Israel,
    • Soroka Medical Center Be'er Sheva, , Israel,
    • Rambam Healthcare Campus Haifa, , Israel,
    • Hadassah Medical Center Jerusalem, , Israel,
    • Rabin Medical Center Petah Tikva, , Israel,
  • Italy,
    • National Cancer Institute, IRCCS, Department of Medical Oncology Milan, , Italy,
    • Santa Maria delle Croci Hospital Ravenna, , Italy,
    • National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1 Rome, , Italy,
  • Netherlands,
    • Erasmus Medical Center Rotterdam, , Netherlands,
  • Spain,
    • University Hospital Germans Trias i Pujol, Department of Medical Oncology Barcelona, , Spain,
    • University Hospital 12 de Octubre Madrid, , Spain,

Sponsors and Collaborators

Spectrum Pharmaceuticals, Inc

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03318939
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Spectrum Pharmaceuticals, Inc:

EGFR

HER2

Exon 20 insertion mutation

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on November 12, 2020