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A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.

NCT04534283 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-07

Study results available
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Summary

The purpose of CTO-IUSCC-0730 study is to assess the clinical efficacy of LY3214996 in combination with abemaciclib at the recommended phase 2 dose of LY3214996 200 mg orally daily and abemaciclib 150 mg orally twice daily. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.

Conditions

  • Cancer
  • Cancer Metastatic
  • BRAF V600E
  • MEK1 Gene Mutation
  • MEK2 Gene Mutation
  • ERK Mutation
  • RAF1 Gene Mutation

Interventions

DRUG

Abemaciclib

Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.

DRUG

LY3214996

Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.

Sponsors & Collaborators

Principal Investigators

  • Anita Turk, MD · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2023-08-07
Completion
2023-08-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534283 on ClinicalTrials.gov