Non-Small Cell Lung Cancer, Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation MedDRA version: 21.1 Level: LLT Classification code 10066490 Term: Progression of non-small cell lung cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Poziotinib Hydrochloride
Product Code: [HM781-36B]
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Poziotinib hydrochloride
CAS Number: 1429757-68-5
Current Sponsor cod
Sponsors
SPECTRUM PHARMACEUTICALS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To continue to monitor patients who appear to derive clinical benefit from poziotinib;Secondary Objective: 1. To evaluate the efficacy of poziotinib in patients 2. To evaluate the safety of poziotinib in patients;Primary end point(s): To continue to monitor patients who appear to derive clinical benefit from poziotinib;Timepoint(s) of evaluation of this end point: The efficacy assessment is evaluated as per “Appendix1. Schedule of Assessments and Procedures” in the study protocol. The study endpoint will be evaluated when either the study is terminated or all patients have End-of-Study Visits whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To evaluate the efficacy of poziotinib in patients 2. To evaluate the safety of poziotinib in patients;Timepoint(s) of evaluation of this end point: The safety assessment is evaluated as per “Appendix1. Schedule of Assessments and Procedures” in the study protocol. The study endpoint will be evaluated when either the study is terminated or all patients have End-of-Study Visits whichever comes first. | — |
Countries
Italy, Netherlands, United States
Contacts
Public ContactSanjay Mourya
Spectrum Pharmaceuticals, Inc.
Outcome results
None listed