Purpose

The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


- At least 18 years of age (participants as young as 12 years of age will be allowed if
permitted by local regulatory authorities).

- Histologically confirmed, unresectable, locally advanced and/or metastatic MTC and no
prior history of treatment with kinase inhibitors for advanced/metastatic disease.

- Radiographic progressive, measurable disease per Response Evaluation Criteria in Solid
Tumors (RECIST) 1.1 at screening compared with a previous image taken within the prior
14 months as assessed by central review.

- A defined/acceptable RET gene alteration identified in a tumor, germline
deoxyribonucleic acid (DNA) or blood sample.

- Tumor tissue in sufficient quantity to allow for retrospective central analysis
of RET mutation status

- Eastern Cooperative Oncology Group performance status score of 0 to 2.

- Adequate hematologic, hepatic, and renal function and electrolytes.

- Men and women of childbearing potential must agree to use a highly effective
contraceptive method during treatment with study drug and for 6 months following the
last dose of study drug.

- Ability to swallow capsules.

Exclusion Criteria:

- An additional validated oncogenic driver in MTC if known that could cause resistance
to selpercatinib treatment. Examples include, but are not limited to RAS gene
mutations and ALK gene fusions.

- Symptomatic central nervous system (CNS) metastases, leptomeningeal carcinomatosis, or
untreated spinal cord compression.

- Clinically significant active cardiovascular disease or history of myocardial
infarction within 6 months, history of Torsades de pointes, or prolongation of the
QTcF >470 milliseconds on more than one electrocardiogram (ECG) during screening.
Participants who are intended to receive vandetanib if randomized to the control arm
ineligible if QTcF is >450 milliseconds.

- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing
uncontrolled intercurrent illness.

- Active hemorrhage or at significant risk for hemorrhage.

- Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or
malignancy diagnosed ≥2 years previously and not currently active. Participants with
multiple endocrine neoplasia type 2 (MEN2) associated pheochromocytoma may be
eligible.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Selpercatinib
Selpercatinib given orally.
  • Drug: Selpercatinib
    Administered orally
    Other names:
    • LY3527723
    • LOXO-292
Active Comparator
Cabozantinib or Vandetanib
Cabozantinib or vandetanib given orally.
  • Drug: Cabozantinib
    Administered orally
  • Drug: Vandetanib
    Administered orally

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
205-934-2762

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.