Study of Experimental Medicine (Poziotinib) in Patients With Non Small Cell Lung Cancer

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"Experimental medicine poziotinib may "target" mutations and stop the growth of this type of cancer"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Non-Small Cell Lung Cancer, NSCLC, metastatic cancer, EGFR, poziotinib
Type: Drug study, Phase 2
Target:
18 Participants
Investigator:
Description
This study is for an investigational study drug called poziotinib. It will be used for the treatment of Non-Small Cell Lung Cancer where certain DNA mutations (EGFR or HER2 Exon 20 Insertion Mutations) are present. Poziotinib is a new type of treatment and is considered investigational. “Investigational” means that it has not yet been approved by the U.S. Food and Drug Administration (FDA).

The surface of lung cells contain some proteins called the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). These proteins play an important part in cell growth and survival. When the proteins of these cells genetically change or have gene mutations, these and other changes can cause cancer or control the growth of cancer. Once these mutations have been identified, it is believed that this study’s treatment with poziotinib may "target" these mutations and stop the growth of this certain type of cancer.

Poziotinib, the “study drug”, is one of a new group of treatments called “targeted therapies”. Targeted therapies are designed to slow or stop certain types cancer cells. They target specific changed or mutated molecules that help cancer cells grow or spread. Poziotinib is given by mouth in the form of a pill. Poziotinib has been studied in over 200 patients with advanced cancers to date.
This study requires

Your study doctor will ask you questions and request medical tests to see if you qualify to be in the study. Your doctor will also evaluate your medical history, current and past medications, current and past medical symptoms, and the status of your cancer. This part of the study is called the screening period. It may take up to 30 days for you to complete all the required tests and evaluations before you can be treated in the study

The study is divided into periods of time for treatment called “cycles”. Each cycle is 28 days. Poziotinib (16 mg) is a pill or pills and will be taken orally once daily with breakfast at approximately the same time each morning. If the morning dose is missed, this dose may be taken any time during the day preferably with food, at least 8 hours prior to the next scheduled dose. On Cycle 2 Day 1, the daily dose will be taken at the clinic after the ECG is performed.

The study doctor will discuss the tests and procedures required for this study in greater detail.

Who can participate

Inclusion criteria:

  • Patient, or patient's authorized representative, must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements
  • Patient has histologically or cytologically confirmed non-small cell lung cancer not amenable to curative intent therapy or stage IV NSCLC
  • Specific mutations:
  • Documented EGFR exon 20 insertion mutation
  • Documented HER2 exon 20 insertion mutation
  • Patient has had at least one prior systemic therapy for metastatic disease
  • Patient has adequate organ function at Baseline
  • Patient is at least 18 years of age

Exclusion criteria:

  • Patient has had previous treatment with poziotinib or any other EGFR or HER2 exon 20 insertion mutation tyrosine kinase inhibitor prior to study participation
  • Patient is concurrently receiving chemotherapy, biologics, immunotherapy for cancer treatment; systemic anti-cancer treatment or investigational treatment
  • Patient has a history of other malignancies within the last 5 years, except for non-melanoma skin cancer or carcinoma in situ of the cervix
  • Patient is pregnant or breast-feeding
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
The maximum amount of time you may participate in this study is 24 months.
Recruitment period
From April 19, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • NSCLC