A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib

NCT03744715 | Terminated Phase 2 FDA Drug

• 2 other identifiers: SPI-POZ-5012020-005213-40
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 5

Brief Summary

This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment who have had previous exposure to poziotinib and/or are still receiving clinical benefit from treatment, as judged by the Investigator or treating physician. Patients must begin treatment in this study within 28 days after their last dose of poziotinib. This extension protocol is intended to provide clinical benefit of poziotinib to patients who are responding to treatment. The additional treatment is optional and voluntary.

Conditions

NSCLC; Breast Cancer

Keywords

EGFR; HER2; Exon 20 insertion mutation; Poziotinib

Outcome Measures

Primary Outcomes (1)

• Number of patients with serious adverse events

  Number of patients with serious adverse events

  24 months

Study Arms (1)

Poziotinib

EXPERIMENTAL

Poziotinib will be taken by the patient orally, once daily with food and a glass of water at approximately the same time. The dose will be the last dose received or at the standard starting dose of 16 mg poziotinib. If a dose is missed, it may be taken any time during the day preferably with food, but at least 8 hours prior to the next scheduled dose.

Drug: Poziotinib

Interventions

Poziotinib DRUG

Poziotinib

Poziotinib

Eligibility Criteria

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

You may qualify if:

• Patient has had previous exposure to poziotinib and is still receiving clinical benefit from treatment, as judged by the Investigator or treating physician.
• Patient must have completed the End of Treatment or End of Study visit if enrolled in a previous (original) poziotinib study.
• Investigator or treating physician opinion indicates that extended therapy with poziotinib is clinically appropriate for the patient and the patient is suitable for this Study.
• Patient agrees to continue study treatment.
• Patient must provide written Informed Consent, must be able to adhere to dosing and visit schedules, and meet protocol-defined study requirements.
• Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of poziotinib.

You may not qualify if:

• Patient has any ongoing adverse event that hasn't improved to Grade ≤1 and could impact the patient's tolerability to poziotinib.
• Patient has an active uncontrolled infection, bleeding disorder, underlying medical condition, or other serious illness that would impair the ability of the patient to receive poziotinib.
• Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the investigator or treating physician.
• Patient last dose of poziotinib was more than 28 days prior to Day 1 of the study.
• Patient is pregnant or breastfeeding.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (5)

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Hattiesburg Clinic Hematology Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15232, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 16, 2018
• Study Start: October 5, 2018
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (5)