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Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer

A Single Arm, Open-label, Multicenter, Multinational, Safety and Efficacy Phase IIIb Trial of BI 695502 Plus mFOLFOX6 in Patients With Previously Untreated Metastatic Colorectal Cancer

NCT02776683•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response \[CR\] plus partial response \[PR\]), overall survival (OS), duration of response (DOR), time to progression (TTP).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females aged \>=18 years (for Japan only: Age \>=20 years at time of signing Informed Consent Form) with histologically confirmed metastatic colorectal cancer (mCRC).
•Metastatic disease not amenable to surgical curative treatment and eligible to receive therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.
•At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
•Adequate hepatic, renal and bone marrow function.

Exclusion Criteria

•Prior systemic therapy for metastatic disease
•Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin® biosimilar
•Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
•Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment
•Any unresolved toxicity \> Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
•History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
•A thrombotic or hemorrhagic event \<=6 months prior to screening (includes hemoptysis, Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage, epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and coronary artery disease)

Locations (46)

Mayo Clinic-Arizona

Phoenix, Arizona, United States

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

The Oncology Institute of Hope and Innovation

Anaheim, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Ashland Bellefonte Cancer Center

Ashland, Kentucky, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Aultman Hospital

Canton, Ohio, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Northwest Cancer Specialists PC

Portland, Oregon, United States

Key Dates

Start Date

June 8, 2016

Primary Completion Date

October 3, 2018

Completion Date

October 3, 2018

Last Updated

November 21, 2019

Enrollment

123

ACTUAL participants

Conditions

Colorectal Neoplasms

Interventions

BI 695502

DRUG

Avastin

DRUG

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

NCT06662786

Colorectal Neoplasms

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RECRUITINGPHASE1

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Colorectal NeoplasmsGastrointestinal Neoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

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Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer

Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.