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

Breast Cancer Clinical Trial

Official title:

An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03744715
• Other study ID #: SPI-POZ-501
• Secondary ID: 2020-005213-40
• Status: Terminated
• Phase: Phase 2
• Start date: October 5, 2018
• Est. completion date: March 3, 2023

Study information

• Verified date: March 2024
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients who wish to participate in the extension study must provide written Informed Consent. Treatment will begin after completion of the End of Study (EOS) or End of Treatment (EOT) visit of the Original Study. The assessments obtained at the EOS or EOT visit will serve as Baseline data for the extension study. Patients will continue to receive poziotinib treatment at the last dose received or at the standard starting dose of 16 milligrams (mg) poziotinib, once daily. Patients may receive treatment as long as the patient is deriving clinical benefit, as judged by the investigator or treating physician (case-by-case decision with approval of Spectrum), death, withdrawal of consent, unacceptable toxicity, lost to follow-up, or poziotinib receives commercial approval in their country of residence or development is terminated by the Sponsor, whichever occurs first. There will be an EOS Visit 35 (±5) days after the last dose of poziotinib.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• NSCLC

Intervention

Drug:
• Poziotinib
Poziotinib

Locations

Country	Name	City	State
United States	Hattiesburg Clinic Hematology Oncology	Hattiesburg	Mississippi
United States	UT MD Anderson Cancer Center	Houston	Texas
United States	Pacific Shores Medical Group	Long Beach	California
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with serious adverse events	Number of patients with serious adverse events	24 months