Study on LY3214996 and Cetuximab, Alone or with Abemaciclib, for Treating Advanced Colorectal Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04616183

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment using LY3214996 and cetuximab, with or without abemaciclib, for patients with colorectal cancer that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to find out if the combination of LY3214996 and cetuximab, with or without abemaciclib, is safe and effective in treating colorectal cancer that cannot be removed by surgery or has spread. Cetuximab is a type of drug that may help stop cancer cells from growing and spreading. LY3214996 and abemaciclib may block certain enzymes that cancer cells need to grow. This study aims to determine the best dose and see how well these treatments work together.

Description

This study is divided into two phases: Phase Ib and Phase II.

In Phase Ib, researchers will determine the safest and most effective dose of LY3214996 when used with cetuximab, and also when used with both cetuximab and abemaciclib. The goal is to find the maximum dose that patients can tolerate without severe side effects.

In Phase II, the study will evaluate how well these treatment combinations work in shrinking tumors, using standard criteria to measure tumor response.

Participants will be assigned to one of two groups:

  • Group A: Participants will take LY3214996 by mouth once a day and receive cetuximab through an IV on specific days. This cycle repeats every 28 days as long as the treatment is effective and side effects are manageable.

  • Group B: Participants will take LY3214996 and cetuximab as in Group A, and will also take abemaciclib by mouth twice a day. This cycle also repeats every 28 days under the same conditions.

After completing the study treatment, participants will be monitored for 30 days to check for any side effects or changes in their health.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of colorectal cancer that cannot be surgically removed or has spread, and is measurable by standard criteria.
  • Have specific genetic markers in the tumor (KRAS, NRAS, EGFR, BRAF wild-type).
  • Have previously received at least one chemotherapy treatment for metastatic colorectal cancer or had cancer return within 6 months after surgery.
  • Have recovered from any side effects of previous treatments.
  • Have a left-sided primary tumor and have been treated with anti-EGFR therapy before.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate blood counts and organ function based on specific lab tests.
  • Women must not be pregnant and must agree to use effective birth control during the study and for a period after.
  • Men must agree to use birth control to prevent fathering a child during the study and for a period after.

Exclusion Criteria

  • Have had a severe allergic reaction to cetuximab.
  • Have a right-sided or transverse colon tumor.
  • Have tumors with certain genetic mutations (KRAS, NRAS, EGFR, BRAF, MEK1).
  • Have an active infection requiring antibiotics.
  • Are taking medications that strongly affect liver enzymes (CYP3A4).
  • Have participated in a similar study before.
  • Have untreated or symptomatic brain metastases.
  • Have had another cancer within the last 3 years, with some exceptions.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have active infections like HIV or hepatitis.
  • Have digestive issues that affect drug absorption.
  • Have any condition that the study doctor believes would make participation unsafe.
  • Have had major surgery recently or have not recovered from it.
  • Are pregnant or breastfeeding.
  • Have any condition that affects the ability to understand the study or follow its requirements.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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