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

Completed · Phase 3

Conditions studied: Colorectal Neoplasms

In brief

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).

Key facts

Study ID

NCT02776683

Run by

Boehringer Ingelheim

People needed

123

Starts

2016-06-08

Expected to finish

2018-10-03

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Further inclusion criteria apply.

You may not qualify if…

• 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)
• Further exclusion criteria apply

Where it is running

• 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
• Willamette Valley Cancer Institute and Research Center — Springfield, Oregon, United States
• Texas Oncology, P.A. — Abilene, Texas, United States
• Texas Oncology, PA, — Amarillo, Texas, United States
• Texas Oncology, P.A. — Austin, Texas, United States
• Texas Oncology, P.A. — Flower Mound, Texas, United States
• Texas Oncology, P.A. — Garland, Texas, United States
• Oncology Consultants, P.A. — Houston, Texas, United States
• Texas Oncology, P.A. — McAllen, Texas, United States
• Texas Oncology, PA — Mesquite, Texas, United States
• Texas Oncology-San Antonio Northeast — San Antonio, Texas, United States
• Texas Oncology San Antonio Medical Center — San Antonio, Texas, United States
• Tyler Hematology-Oncology, PA — Tyler, Texas, United States
• Texas Oncology, P.A. — Tyler, Texas, United States
• Texas Oncology, P.A., Deke Slayton Cancer Center — Webster, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.