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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03744715.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
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.
Lead OrganizationSpectrum Pharmaceuticals Inc