Targeting RET

About the ARROW clinical trial

The ARROW clinical trial will test an investigational drug called pralsetinib (formerly known as BLU-667) in people who have RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) or another solid tumor that has a RET fusion or mutation. It is a phase 1/2 trial designed to test the safety and the initial clinical activity of pralsetinib.

Information about RET-altered cancers

All cancers begin when one or more genes are mutated (altered) and the cell starts to divide and grow out of control. Identifying these genes is important, because drugs can be developed to target them.

RET fusions and mutations are specific alterations that are sometimes found in a gene called RET. This gene provides the instructions for making the RET protein that is involved in important cell functions. RET alterations have been shown to cause non-small cell lung cancer, medullary thyroid cancer and other solid tumors in some people. Pralsetinib is an investigational drug that was specifically designed to inhibit (block) altered forms of RET.

What does taking part in the ARROW clinical trial involve?

Up to 28 days

To assess your suitability for the trial.

28-day cycles*

All participants will receive the investigational drug for a minimum of 28 days (1 cycle)

All participants must have a follow-up visit 14 days after their last dose of investigational drug. At 30 days, we will give participants a follow-up call and then again every 3 months until disease progression.

*There is no maximum duration for this trial. You will continue with your cycles of treatment until:
*Your disease worsens * You can’t tolerate any side effects you may have *You decide to leave the trial * The trial doctor decides you should leave the trial * The trial sponsor decides to discontinue the trial

ARROW Trial Clinic Visits

During the trial, a variety of health assessments will be conducted to see how you are responding to the investigational drug. In most cases, these assessments will be done at a clinical site.

Health assessments will vary between visits, but may include:

MRI or CT scan

Vital signs

(temperature, blood pressure, heart rate and weight)

ECG

(painless heart scan)

Blood tests

How often will these visits take place?*

6 times

Cycle 1

Cycle 2

2 times

Cycle 3 onwards

Once per cycle

How can I learn more about the ARROW trial?

If you think you meet the criteria specified above and are interested in taking part in the ARROW trial, or you would simply like more information, please call: +1 617-714-6707 or email: ARROW@blueprintmedicines.com. A member of our team will talk you through the next steps and will connect you to a suitable trial doctor.