MedTrace Logo

MEK Inhibitor MEK162 in Combination With Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Metastatic Colorectal Cancer

NCT02041481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-01-25

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of MEK inhibitor MEK162 when given together with leucovorin calcium, fluorouracil, and oxaliplatin in treating patients with advanced metastatic colorectal cancer. MEK inhibitor MEK162 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162 with leucovorin calcium, fluorouracil, and oxaliplatin may kill more tumor cells.

Conditions

  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer

Interventions

DRUG

MEK inhibitor MEK162

Given PO

DRUG

leucovorin calcium

Given IV

DRUG

fluorouracil

Given IV

DRUG

oxaliplatin

Given IV

OTHER

pharmacological study

Correlative studies

OTHER

Laboratory Biomarker Analysis

Correlative Studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Array BioPharma

    collaborator INDUSTRY

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Marwan Fakih · City of Hope Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-01-19
Completion
2018-01-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02041481 on ClinicalTrials.gov