NON-FUNCTIONING PITUITARY ADENOMA

How are my rights and safety protected as a patient during a clinical study?

Non-Functioning Pituitary Adenoma or NFPAs are tumors that form in and around the pituitary gland.

Protecting the rights, wellbeing, and safety of clinical study patients is a top priority for clinical researchers and physicians throughout the clinical study process. Clinical studies follow strict federal guidelines regarding the treatment of volunteers, and all processes and materials must be investigated by an independent ethics committee called the Institutional Review Board (IRB). All aspects of the study will be explained to you by the study personnel, and you will have the opportunity to ask questions or voice concerns.

How does a clinical study evaluate an investigational medicine?

Clinical studies have a structured process for visits, medical assessments, and a dosing schedule the patient must follow. Information about how you feel and how you are reacting to the study treatment is collected.

Can I leave the clinical study before it ends?

WELCOME TO THE Lightbeam Study!

A Phase 2 clinical trial investigating the safety and tolerability of an investigational medication in adult patients with a non-functioning pituitary adenoma (NFPA).

The standard of care therapy is transsphenoidal surgery (TSS) to allow decompression of tumor. However, given the location of these tumors, complete surgical resection may be limited by other local anatomical structures, causing many patients to have residual tumor remnants post-surgery, which can continue to grow after surgery. Repeat surgery or radiation therapy may be required, which carries increased risk to the patient.

Do I Qualify?

Qualified participants must:

• Be between the ages of 18-80 years old with a confirmed diagnosis of NFPA

• Be on a stable dose of hormone replacement therapy

• Have not undergone radiation therapy to the head

• Have not had more than one transsphenoidal surgery (TSS)

• Have no history of psychotic disorder

• Have no allergies to contrast dye

• Have no history of uncontrolled diabetes

THIS STUDY

IS SPONSORED BY: [SITE

Clinical Research Study for Patients with Non-Functioning Pituitary Adenoma (NFPA)

Consider participating in a clinical research trial and help to advance medical options for patients with NFPA.

Tiburio_TBR-760-NFPA-201_Brochure_EN-US_Version 1_FINAL_03 Sept 2019