A Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study
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|ClinicalTrials.gov Identifier: NCT03744715|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Breast Cancer||Drug: Poziotinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Extension Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study|
|Actual Study Start Date :||October 5, 2018|
|Estimated Primary Completion Date :||October 5, 2023|
|Estimated Study Completion Date :||April 5, 2026|
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 same as the dose at the end of the Original Study unless modified. If a dose is missed, it may be taken any time during the day preferably with food, at least 8 hours prior to the next scheduled dose.
- Number of patients with serious adverse events [ Time Frame: 24 months ]Number of patients with serious adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744715
|Contact: Bill Paxton, MD||949-743-9259||Bill.Paxton@sppirx.com|
|United States, Mississippi|
|Hattiesburg Clinic Hematology Oncology||Recruiting|
|Hattiesburg, Mississippi, United States, 39401|
|Contact: Tammy McBeth 601-288-2495|