The CARE Study is enrolling individuals in a Phase 1/2 multi-center study evaluating an investigational drug, repotrectinib, for the treatment of children and young adults with advanced or solid tumors, primary CNS tumors, or anaplastic large cell lymphoma (ALCL) with ALK+, ROS1+, or NTRK+ alterations.
WHAT DOES IT MEAN TO BE ALK+, ROS1+, or NTRK+?
All cancers begin when one or more genes change/rearrange and the cell starts to divide and grow out of control. Identifying these abnormal genes is important because drugs can be developed to target and stop them.
A ROS1+ rearrangement is an abnormality in a gene that can occur in cancer cells, such as lung cancer cells. NTRK+ gene abnormalities can occur in various solid tumor cancers. ALK+ rearrangement is an alteration of the lung cells’ DNA that causes cells to grow abnormally and behave as cancer cells.
The CARE Study is a clinical study that is evaluating whether repotrectinib is effective in children and young adults with advanced or solid tumors, primary CNS tumors, or anaplastic large cell lymphoma (ALCL) with ALK+, ROS1+, or NTRK+ alterations.
About the Investigational Drug
Tyrosine Kinase Inhibitors (TKIs) like the investigational drug repotrectinib are targeted therapies that attack cancer cells.
Cancer cells often develop mutations (changes in the genetic material of a cell) that prevent entry for TKIs to hit their target. Repotrectinib is designed to inhibit (block) rearranged forms of ROS1, ALK, and TRK and to be small enough to potentially bypass the barriers caused by two common types of mutations: 1) solvent front and 2) gatekeeper. The CARE Study is evaluating repotrectinib in advanced or solid tumors, primary CNS tumors, or anaplastic large cell lymphoma (ALCL) in individuals that have tested positive for ALK+, ROS1+, or NTRK+ alterations.
Repotrectinib comes in pill or liquid form and is taken by mouth.
WHAT DOES TAKING PART IN THE CARE STUDY INVOLVE?
SCREENING:
To participate, you/your loved one will need to be evaluated to determine if you/they are eligible to participate. It may take up to 28-days to evaluate a potential individual’s eligibility for the study.
DOSING PERIOD:
If eligible to participate, you/your loved one will take the investigational drug daily for 28 days in each cycle (28-day cycles* = approximately one month).
**There is no maximum duration for this study. Participants can continue with cycles of study treatment until any of the following occur: you/your loved one’s disease worsens, you decide that you/your loved one will no longer participate in the study, the study doctor decides you/your loved one should no longer participate in the study, the study sponsor decides to stop the study.
FOLLOW UP PERIOD:
Once you or your loved one stops taking the investigational drug, a follow-up visit will be performed to see how you/they are doing. The follow-up visit will occur 28 days after the last dose of the investigational drug, and then a check-in via phone every 3 months.
HOW COULD I PARTICIPATE IN THE STUDY?
Children and young adults up to age 25 who have advanced or metastatic solid tumors are eligible to participate.
Clinical study eligibility requirements will apply, and only a qualified healthcare professional can determine if you or a loved one is eligible to participate in the study.
STUDY SITE LOCATIONS
Find a participating U.S. site location near you. Fill out the form below to help determine if you or a loved is eligible for participation in the CARE Study.
Clinical study eligibility requirements will apply, and only a qualified healthcare professional can determine if you or a loved one are eligible to participate in the study.
HOW CAN I LEARN MORE ABOUT THE CARE STUDY?
If you are located in the United States and interested in learning more about the CARE Study, please complete the following questionnaire and a study representative will contact you within 2-3 business days. You can also contact us directly at (855) 613-3355 (M-F from 8am to 8pm EST). If you are under 18 years of age, please ask your parent or guardian to complete the questionnaire below and contact us directly for further information at (855) 613-3355 (M-F from 8am to 8pm EST).
* Indicates Required Field
Frequently Asked Questions
What is a clinical study?
A clinical study is a type of research study designed to evaluate whether an investigational drug is safe and effective for use in humans. Participants are given specific investigational treatments and researchers closely monitor the results to help determine if the drug should be approved for wider use. The U.S. Food and Drug Administration (FDA) has strict rules that govern how clinical studies are conducted, and requires that an investigational drug be proven safe and effective before it can be widely used in the United States.
What is an investigational drug?
An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) but can be administered to people in a clinical study for research purposes.
What type of clinical study is the CARE Study?
The CARE Study is a phase 1/2 clinical study evaluating an investigational drug, repotrectinib, for the treatment of children and young adults (under age 25) with advanced or solid tumors, primary CNS tumors, or anaplastic large cell lymphoma (ALCL) with ALK+, ROS1+, or NTRK+ alterations. There is no cost to participate in the study and there is no maximum duration for this study. Participants can continue with cycles of treatment until any of the following occur: you/your loved one’s disease worsens, you decide that you/your loved one will no longer participate in the study, the study doctor decides you/your loved one should no longer participate in the study, the study sponsor decides to stop the study.
How can I learn more about the investigational medication and this study?
More information on this clinical study can be found on clinicaltrials.gov (Protocol number TPX-0005-07) or Turning Point Therapeutics Website.
Study Site Locations
Current U.S. study locations are listed below, and more may be added as they open. If you or a loved one is interested in participating in the CARE Study complete the form to speak with a study representative who can also provide available study locations.
Help spread awareness of the CARE Study by sharing with others! To share this study information via email, click here.
