Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 1Phase 2 Interventional Results available

ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT01075048

Public ClinicalTrials.gov record NCT01075048. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 6:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Placebo-Controlled, Phase 1/2 Study Of ARQ 197 in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Who Have Received Front-Line Systemic Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2. After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.

Study identification

NCT ID
NCT01075048
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
131 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 25, 2010
Primary completion
Oct 11, 2012
Completion
Feb 19, 2015
Last update posted
Apr 7, 2021

2010 – 2015

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
24
Facility City State ZIP Site status
Not listed Beverly Hills California 90211-1850
Not listed Encinitas California 92024
Not listed Fountain Valley California 92708
Not listed Riverside California 92501
Not listed Fort Collins Colorado 80528
Not listed Norwich Connecticut 06360
Not listed Boynton Beach Florida 33435
Not listed Fort Myers Florida 33916
Not listed Orlando Florida 32836
Not listed Centralia Illinois 62801
Not listed Metairie Louisiana 70006
Not listed Baltimore Maryland 21237
Not listed Hagerstown Maryland 21740
Not listed Omaha Nebraska 68114
Not listed Buffalo New York 14263
Not listed Lake Success New York 11042
Not listed Canton Ohio 44718
Not listed Cincinnati Ohio 45242
Not listed Oklahoma City Oklahoma 73104
Not listed Charleston South Carolina 29403
Not listed Columbia South Carolina 29210
Not listed Nashville Tennessee 372203
Not listed Houston Texas 77030
Not listed Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01075048, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 7, 2021 · Synced Sep 5, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01075048 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →