A Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:October 5, 2018
End Date:April 5, 2026
Contact:Zane Yang, MD
Email:zane.yang@sppirx.com
Phone:(949) 743-9291

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An Open-Label, Extension Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study

This is an open-label extension study (Extension Study) designed to allow patients to
continue to receive poziotinib treatment after they have completed the duration of treatment
and all protocol-specified assessments and procedures in a previous Spectrum-sponsored
poziotinib study (Original Study). Patients will proceed to the study with a maximum hiatus
of 20 days following the End-of-Treatment (EOT) visit in the Original Study.

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.

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 EOT visit of the
Original Study. The assessments obtained at the EOS visit will serve as Baseline data for the
extension study. If a patient in the Original Study was to undergo an EOT visit and an EOS
visit with no treatment administered between these two assessments, the patient, if consented
to this Extension Study must enroll right after (with a maximum hiatus of 20 days) the EOT
Visit of the Original Study so that the treatment will continue without a break.

Patients will continue to receive poziotinib treatment at the dose and regimen they were
receiving at the end of the Original Study.

Patients may receive treatment until disease progression or as long as the patient is
deriving clinical benefit, as judged by the investigator (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.

Inclusion Criteria:

- Patient has participated in and completed all protocol-specified assessments for a
Spectrum-sponsored clinical Study with poziotinib.

- Patient must have completed the End of Treatment or End of Study visit of the original
Spectrum-sponsored Study.

- Patient did not meet any treatment discontinuation criteria other than completing
maximum treatment time of the original Spectrum-sponsored Study.

- Investigator 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 as defined in the original clinical study
protocol.

- 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 could impact 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 is receiving any other treatment modalities with curative intent for his or
her malignancy, including investigational products other than poziotinib. Therapies to
palliate local symptoms will be allowed (e.g. radiation for focal bone metastasis).

- Patient has any medical or non-medical condition that may not be suitable for
poziotinib treatment, as determined by the investigator.

- Patient is pregnant or breastfeeding.
We found this trial at
1
site
Hattiesburg, Mississippi 39401
Phone: 601-288-2495
?
mi
from
Hattiesburg, MS
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