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

NCT ID: NCT03744715

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-05
• Study Completion Date: 2023-03-03

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.

Detailed 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.

Conditions

NSCLC; Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Poziotinib

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.

Group Type: EXPERIMENTAL

Poziotinib

Intervention Type: DRUG

Poziotinib

Interventions

Poziotinib

Poziotinib

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pacific Shores Medical Group

Long Beach, California, United States

Hattiesburg Clinic Hematology Oncology

Hattiesburg, Mississippi, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

UPMC

Pittsburgh, Pennsylvania, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

2020-005213-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPI-POZ-501

Identifier Type: -

Identifier Source: org_study_id