Clinical trial NCT02776683: Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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.
* Further inclusion criteria apply.

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)
* Further exclusion criteria apply

Primary outcomes:
measure: Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment
timeFrame: From baseline up to 18 weeks after the last dose of trial medication prior to the Switch Visit. Maximum duration of up to 32 treatment cycles + safety follow up (up to 82 weeks overall).
Secondary outcomes:
measure: Duration of Response (DOR) as Assessed by Central Imaging Review
timeFrame: Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
measure: Time to Progression (TTP) as Assessed by Central Imaging Review
timeFrame: Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
measure: Objective Response (OR) Rate as Assessed by Central Imaging Review
timeFrame: Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
measure: Overall Survival (OS) Time
timeFrame: From date of first dose of trial medication until last date of trial medication + 18 weeks (REP), up to a maximum of 32 treatment cycles + safety follow up (up to 82 weeks overall).
measure: Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review
timeFrame: Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic-Arizona
state: Arizona
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Anaheim
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Ashland
country: United States
facility: Ashland Bellefonte Cancer Center
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Portland
country: United States
facility: Northwest Cancer Specialists PC
state: Oregon
city: Springfield
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Abilene
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Amarillo
country: United States
facility: Texas Oncology, PA,
state: Texas
city: Austin
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Garland
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: McAllen
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Mesquite
country: United States
facility: Texas Oncology, PA
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology San Antonio Medical Center
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology-Oncology, PA
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Webster
country: United States
facility: Texas Oncology, P.A., Deke Slayton Cancer Center
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Chiba, Chiba
country: Japan
facility: Chiba Cancer Center
city: Ehime, Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Hokkaido, Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Hyogo, Amagasaki
country: Japan
facility: Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
city: Kagawa, Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Osaka, Suita
country: Japan
facility: Osaka University Hospital
city: Tokyo, Koto-ku
country: Japan
facility: Jananese Foundation for Cancer Research
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Chernivtsi
country: Ukraine
facility: CI Chernivtsi RC Oncological Dispensary Bukovinian SMU
city: Dnipropetrovsk
country: Ukraine
facility: Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Clinical Oncological Dispensary, Ivano-Frankivsk
city: Kharkiv
country: Ukraine
facility: CI of PH Kharkiv CCH #2
city: Kirovohrad
country: Ukraine
facility: Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad
city: Kryvyi Rih, Dnipropetrovsk
country: Ukraine
facility: CI Kryvyi Rih Oncological Dispensary of DRC
city: Kyiv
country: Ukraine
facility: National Institute of Cancer
city: Lviv
country: Ukraine
facility: CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Oncological Dispensary, Poltava
city: Sumy
country: Ukraine
facility: Sumy Regional Oncology Center
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncological Dispensary
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: