A Phase 3 Trial with RET-Mutant Medullary Thyroid Cancer

Phase 3

• Conditions: Health Condition 1: E079- Disorder of thyroid, unspecified

• Registration Number: CTRI/2020/04/024493
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

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

3. 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.

4. 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

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

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

7. 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.

8. 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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Failure-Free Survival (TFFS) by Blinded Independent Committee Review (BICR)Timepoint: Baseline to Progressive Disease, Unacceptable Toxicity or Death from Any Cause (Estimated at up to 30 Months)