An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients who have had Previous Exposure to Poziotinib - SPI-POZ-501

SPECTRUM PHARMACEUTICALS0 个研究点目标入组 40 人开始时间: 2021年8月30日最近更新: 2024年3月12日

试验速览

暂无简介。

•1. Patient has had previous exposure to poziotinib and is still receiving clinical benefit from treatment, as judged by the Investigator or treating physician.
•2. Patient must have completed the End-of-Treatment or End-of-Study Visit if enrolled in a previous (original) poziotinib study.
•3. 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.
•4. Patient agrees to continue study treatment.
•5. Patient must provide written Informed Consent, must be able to adhere to dosing and visit schedules, and meet protocol-defined study requirements.
•6. 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Patient has any ongoing adverse event that hasn't improved to Grade =1 and could impact the patient's tolerability to poziotinib.
•2. 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.
•3. Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the Investigator or treating physician.
•4. Patient's last dose of poziotinib was more than 28 days prior to Day 1 of the study.
•5. Patient is pregnant or breastfeeding.

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