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Protocol # 17-241

Status

Recruiting

Description

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

Condition

  • Non-Small Cell Lung Cancer
  • Medullary Thyroid Cancer
  • Colon Cancer
  • Any Solid Tumor

Interventions

  • LOXO-292

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Phase 1: MTD
  • Phase 1: RP2D
  • Phase 2: Objective Response Rate

Secondary Outcome:

  • Phase 1: Number of Participants with a Treatment-Related Adverse Event(s) (TRAE[s])
  • Phase 1: Number of Participants with an Abnormal Laboratory or Physical Exam Result(s)
  • Phase 1: Overall Response Rate (ORR) based on RECIST 1.1 or RANO, as Appropriate to Tumor Type
  • Phase 2: ORR (by Investigator)
  • Phase 2: Best Change in Tumor Size from Baseline (by IRC and Investigator)
  • Phase 2: Duration of Response (DOR; by IRC and Investigator)
  • Phase 2: Central Nervous System (CNS) ORR (by IRC)
  • Phase 2: CNS DOR (by IRC)
  • Phase 2: Time to Any and Best Response (by IRC and Investigator)
  • Phase 2: CBR (by IRC and Investigator)
  • Phase 2: PFS (by IRC and Investigator)
  • Phase 2: Overall Survival (OS)
  • Phase 2: Percentage of Participants with any Serious Adverse Event (SAE[s])
  • Phase 1 and 2: Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve of LOXO-292 (Selpercatinib)
  • Phase 1 and 2: PK: Maximum Concentration (Cmax) of LOXO-292 (Selpercatinib)

Enrollment

875

Study Start Date

May 2, 2017

Eligibility

  • Gender:     All
  • Minimum age:     12 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Loxo Oncology, Inc.

Source

Eli Lilly and Company

Official title

A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

Clinicaltrials.gov Identifier

NCT03157128

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.