A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged DuringTransfection (RET) Activation (LIBRETTO-201) - LIBRETTO-201

OXO ONCOLOGY INCORPORATED0 sites450 target enrollmentSeptember 1, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 1, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OXO ONCOLOGY INCORPORATED

•Major Inclusion Criteria:
•1\. Patients with a locally advanced or metastatic solid tumor with RET activation who:
•Are not eligible for an ongoing selpercatinib clinical trial (e.g., for clinical, geographic or financial reasons or due to cohort closure), but are deemed appropriate candidates to receive selpercatinib treatment by the Investigator and the Sponsor, and
•Have progressed on or are intolerant to standard therapy, or
•No standard therapy exists, or
•In the opinion of the Investigator, are not candidates for or who would be unlikely to derive significant clinical benefit from standard therapy
•Patients eligible for LIBRETTO\-001 and/ or Phase 3 trials who are being considered for the EAP must be discussed with the Medical Monitor prior to screening.
•2\. Evidence of an activating RET gene alteration from a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/independent ethics committee (IEC), College of American Pathologists (CAP), or other similar certification.
•3\. Eighteen years of age or older at the time of consent.
•4\. Adequate hematologic, renal and hepatic function as defined in Section 6\.1\.

•Major Exclusion Criteria:
•1\. Investigational agent (via clinical trial) or anticancer therapy within 5 half\-lives or 2 weeks (whichever is shorter) prior to planned start of selpercatinib unless considered by the Investigator to be safe, within the best interest of the patient and with prior Sponsor approval.
•2\. Clinically significant active cardiovascular disease (including NYHA class III/IV heart failure, stroke, severe valvular disease or uncontrolled hypertension defined as \= 140/80 sustained over multiple readings) or history of myocardial infarction within 6 months prior to Cycle 1, Day 1 (C1D1\); ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) interval \> 470 msec. Patients who meet this criteria may be enrolled (with a modified dosing strategy) if a clinical rationale exists which is reviewed and agreed upon by the Sponsor.
•3\. Current treatment with strong cytochrome P450 3A4 (CYP3A4\) inhibitors or inducers (refer to Section 1\.6\.3\).
•4\. Current treatment with proton\-pump inhibitors (PPIs). Note: Treatment with PPIs must be stopped 1 or more weeks prior to the first dose of selpercatinib.
•Complete EAP eligibility criteria are presented in Section 4\.