Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02149108
Other study ID # 1199.52
Secondary ID 2012-000095-42
Status Completed
Phase Phase 3
First received May 26, 2014
Last updated August 26, 2016
Start date September 2014
Est. completion date August 2016

Study information

Verified date August 2016
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Dept of Health and Ageing Therapeutic Goods AdministrationAustria: Austrian Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicinal and Health ProductsCanada: Health CanadaCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Agence Nationale sécurité médicament et des produits santéGermany: Federal Institute for Drugs and Medical DevicesHong Kong: Department of HealthIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: AIFA (Italian Medicine Agency)Japan: Ministry of Health, Labor and WelfareKorea: Ministry of Food and Drug SafetyLuxembourg: Ministère de la SantéMexico: Federal Commission for Protection Against Health RisksNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Registration Medicinal Product Medical Device Biocidal ProductRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of Medicines and Medical DevicesSweden: Medical Products AgencyTaiwan : Food and Drug AdministrationTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationPortugal: INFARMED, National Authority of Medicines and Health Products, IP
Study type Interventional

Clinical Trial Summary

The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.


Recruitment information / eligibility

Status Completed
Enrollment 768
Est. completion date August 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Age >= 18 years

- Signed informed consent

- Histologically or cytologically confirmed colorectal adenocarcinoma

- Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status = 1

- At least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

- Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:

- - fluoropyrimidine

- - oxaliplatin: Patients treated with oxalipatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease

- - irinotecan

- - bevacizumab or aflibercept

- - cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumours

- - The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS 102 are allowed and these agents should be administered before study if available to patient according to local standards)

- - Life expectancy of at least 12 weeks

- - Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Tranferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin < 2 X ULN and normal AST/ALT are eligible

- Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN

Exclusion criteria:

- Previous treatment with nintedanib

- toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1

- History of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results.

- Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,

- Significant cardiovascular diseases

- History of severe haemorrhagic or thromboembolic event in the past 12 months

- Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring

- Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug

- Patient with brain metastases that are symptomatic and/or require therapy.

- Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception

- Pregnancy or breast-feeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nindetanib (BIBF 1120)

Placebo

BSC

BSC


Locations

Country Name City State
Argentina 1199.52.5404 Boehringer Ingelheim Investigational Site Cdad. de Córdoba
Argentina 1199.52.5405 Boehringer Ingelheim Investigational Site Cdad. de Córdoba
Argentina 1199.52.5401 Boehringer Ingelheim Investigational Site Ciudad Autónoma de Bs As
Argentina 1199.52.5403 Boehringer Ingelheim Investigational Site Ciudad Autónoma de Bs As
Argentina 1199.52.5406 Boehringer Ingelheim Investigational Site Ciudad Autónoma de Bs As
Australia 1199.52.6102 Boehringer Ingelheim Investigational Site Concord New South Wales
Australia 1199.52.6104 Boehringer Ingelheim Investigational Site Heidelberg Victoria
Australia 1199.52.6105 Boehringer Ingelheim Investigational Site Nedlands Western Australia
Australia 1199.52.6106 Boehringer Ingelheim Investigational Site Perth Western Australia
Australia 1199.52.6103 Boehringer Ingelheim Investigational Site St Leonards New South Wales
Australia 1199.52.6101 Boehringer Ingelheim Investigational Site Wollongong New South Wales
Austria 1199.52.4302 Boehringer Ingelheim Investigational Site Linz
Austria 1199.52.4303 Boehringer Ingelheim Investigational Site Wien
Austria 1199.52.4304 Boehringer Ingelheim Investigational Site Wien
Belgium 1199.52.3208 Boehringer Ingelheim Investigational Site Aalst
Belgium 1199.52.3205 Boehringer Ingelheim Investigational Site Bonheiden
Belgium 1199.52.3202 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 1199.52.3207 Boehringer Ingelheim Investigational Site Charleroi
Belgium 1199.52.3204 Boehringer Ingelheim Investigational Site Edegem
Belgium 1199.52.3203 Boehringer Ingelheim Investigational Site Haine-Saint-Paul
Belgium 1199.52.3201 Boehringer Ingelheim Investigational Site Leuven
Belgium 1199.52.3206 Boehringer Ingelheim Investigational Site Liège
Belgium 1199.52.3521 Boehringer Ingelheim Investigational Site Luxembourg
Canada 1199.52.1004 Boehringer Ingelheim Investigational Site Edmonton Ontario
Canada 1199.52.1002 Boehringer Ingelheim Investigational Site Montreal Quebec
Canada 1199.52.1001 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 1199.52.1003 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Czech Republic 1199.52.4202 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1199.52.4204 Boehringer Ingelheim Investigational Site Hradec Kralove
Czech Republic 1199.52.4201 Boehringer Ingelheim Investigational Site Prague
Denmark 1199.52.4502 Boehringer Ingelheim Investigational Site Herning
Denmark 1199.52.4501 Boehringer Ingelheim Investigational Site København Ø
Denmark 1199.52.4503 Boehringer Ingelheim Investigational Site Næstved
Denmark 1199.52.4504 Boehringer Ingelheim Investigational Site Odense C
France 1199.52.3304 Boehringer Ingelheim Investigational Site Lille cedex
France 1199.52.3307 Boehringer Ingelheim Investigational Site Lyon cedex 8
France 1199.52.3305 Boehringer Ingelheim Investigational Site Paris cedex 15
France 1199.52.3301 Boehringer Ingelheim Investigational Site Reims Cedex
Germany 1199.52.4906 Boehringer Ingelheim Investigational Site Dresden
Germany 1199.52.4905 Boehringer Ingelheim Investigational Site Essen
Germany 1199.52.4904 Boehringer Ingelheim Investigational Site Freiburg
Germany 1199.52.4903 Boehringer Ingelheim Investigational Site Mannheim
Germany 1199.52.4901 Boehringer Ingelheim Investigational Site Ulm
Hong Kong 1199.52.8501 Boehringer Ingelheim Investigational Site Hong Kong
Hong Kong 1199.52.8502 Boehringer Ingelheim Investigational Site Hong Kong
Hong Kong 1199.52.8503 Boehringer Ingelheim Investigational Site Hong Kong
Hong Kong 1199.52.8504 Boehringer Ingelheim Investigational Site Hong Kong
Israel 1199.52.9706 Boehringer Ingelheim Investigational Site Beer Sheva
Israel 1199.52.9704 Boehringer Ingelheim Investigational Site Petach Tikva
Israel 1199.52.9703 Boehringer Ingelheim Investigational Site Tel Aviv
Italy 1199.52.3901 Boehringer Ingelheim Investigational Site Genova
Italy 1199.52.3906 Boehringer Ingelheim Investigational Site Milano
Italy 1199.52.3907 Boehringer Ingelheim Investigational Site Napoli
Italy 1199.52.3905 Boehringer Ingelheim Investigational Site Padova
Italy 1199.52.3903 Boehringer Ingelheim Investigational Site Pisa
Italy 1199.52.3904 Boehringer Ingelheim Investigational Site San Giovanni Rotondo (FG)
Japan 1199.52.8102 Boehringer Ingelheim Investigational Site Aichi, Nagoya
Japan 1199.52.8105 Boehringer Ingelheim Investigational Site Chiba, Chiba
Japan 1199.52.8101 Boehringer Ingelheim Investigational Site Chiba, Kashiwa
Japan 1199.52.8107 Boehringer Ingelheim Investigational Site Ehime, Matsuyama
Japan 1199.52.8106 Boehringer Ingelheim Investigational Site Fukuoka, Fukuoka
Japan 1199.52.8108 Boehringer Ingelheim Investigational Site Hokkaido, Sapporo
Japan 1199.52.8115 Boehringer Ingelheim Investigational Site Hyogo, Amagasaki
Japan 1199.52.8112 Boehringer Ingelheim Investigational Site Hyogo, Kobe
Japan 1199.52.8114 Boehringer Ingelheim Investigational Site Ibaraki, Tsukuba
Japan 1199.52.8110 Boehringer Ingelheim Investigational Site Oita, Yufu
Japan 1199.52.8116 Boehringer Ingelheim Investigational Site Osaka, Osaka
Japan 1199.52.8103 Boehringer Ingelheim Investigational Site Osaka, Suita
Japan 1199.52.8109 Boehringer Ingelheim Investigational Site Saitama, Kitaadachi-gun
Japan 1199.52.8104 Boehringer Ingelheim Investigational Site Shizuoka, Sunto-gun
Japan 1199.52.8113 Boehringer Ingelheim Investigational Site Tokyo , Shinagawa-ku
Japan 1199.52.8111 Boehringer Ingelheim Investigational Site Tokyo, Koto-ku
Korea, Republic of 1199.52.8202 Boehringer Ingelheim Investigational Site Goyang
Korea, Republic of 1199.52.8201 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1199.52.8203 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1199.52.8204 Boehringer Ingelheim Investigational Site Seoul
Mexico 1199.52.5201 Boehringer Ingelheim Investigational Site Mexico
Netherlands 1199.52.3101 Boehringer Ingelheim Investigational Site Amsterdam
Netherlands 1199.52.3103 Boehringer Ingelheim Investigational Site Amsterdam
Netherlands 1199.52.3102 Boehringer Ingelheim Investigational Site Utrecht
Poland 1199.52.4801 Boehringer Ingelheim Investigational Site Jelenia Gora
Poland 1199.52.4803 Boehringer Ingelheim Investigational Site Poznan
Poland 1199.52.4804 Boehringer Ingelheim Investigational Site Wroclaw
Portugal 1199.52.3504 Boehringer Ingelheim Investigational Site Almada
Portugal 1199.52.3502 Boehringer Ingelheim Investigational Site Coimbra
Portugal 1199.52.3505 Boehringer Ingelheim Investigational Site Loures
Portugal 1199.52.3501 Boehringer Ingelheim Investigational Site Porto
Portugal 1199.52.3506 Boehringer Ingelheim Investigational Site Porto
Russian Federation 1199.52.0701 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1199.52.0703 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1199.52.0702 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1199.52.0707 Boehringer Ingelheim Investigational Site Tyumen
Spain 1199.52.3401 Boehringer Ingelheim Investigational Site Barcelona
Spain 1199.52.3402 Boehringer Ingelheim Investigational Site L'Hospitalet de Llobregat
Spain 1199.52.3406 Boehringer Ingelheim Investigational Site La Coruña
Spain 1199.52.3403 Boehringer Ingelheim Investigational Site Madrid
Spain 1199.52.3404 Boehringer Ingelheim Investigational Site Madrid
Spain 1199.52.3405 Boehringer Ingelheim Investigational Site Santander
Spain 1199.52.3407 Boehringer Ingelheim Investigational Site Sevilla
Sweden 1199.52.4601 Boehringer Ingelheim Investigational Site Stockholm
Sweden 1199.52.4602 Boehringer Ingelheim Investigational Site Uppsala
Taiwan 1199.52.8805 Boehringer Ingelheim Investigational Site Kaohsiung
Taiwan 1199.52.8801 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1199.52.8803 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1199.52.8802 Boehringer Ingelheim Investigational Site Taoyuan County
Turkey 1199.52.9005 Boehringer Ingelheim Investigational Site Adana
Turkey 1199.52.9001 Boehringer Ingelheim Investigational Site Ankara
Turkey 1199.52.9003 Boehringer Ingelheim Investigational Site Antalya
Turkey 1199.52.9004 Boehringer Ingelheim Investigational Site Istanbul
Turkey 1199.52.9002 Boehringer Ingelheim Investigational Site Izmir
United Kingdom 1199.52.4401 Boehringer Ingelheim Investigational Site Aberdeen
United Kingdom 1199.52.4403 Boehringer Ingelheim Investigational Site Manchester
United Kingdom 1199.52.4402 Boehringer Ingelheim Investigational Site Middlesex
United Kingdom 1199.52.4405 Boehringer Ingelheim Investigational Site Nottingham
United Kingdom 1199.52.4404 Boehringer Ingelheim Investigational Site Southampton
United States 1199.52.0121 Boehringer Ingelheim Investigational Site Arlington Heights Illinois
United States 1199.52.0115 Boehringer Ingelheim Investigational Site Canton Ohio
United States 1199.52.0113 Boehringer Ingelheim Investigational Site Detroit Michigan
United States 1199.52.0120 Boehringer Ingelheim Investigational Site Fort Worth Texas
United States 1199.52.0119 Boehringer Ingelheim Investigational Site Johnson City New York
United States 1199.52.0108 Boehringer Ingelheim Investigational Site Los Angeles California
United States 1199.52.0102 Boehringer Ingelheim Investigational Site Nashville Tennessee
United States 1199.52.0105 Boehringer Ingelheim Investigational Site New Haven Connecticut
United States 1199.52.0114 Boehringer Ingelheim Investigational Site New Orleans Louisiana
United States 1199.52.0125 Boehringer Ingelheim Investigational Site Omaha Nebraska
United States 1199.52.0101 Boehringer Ingelheim Investigational Site Plainville Connecticut
United States 1199.52.0123 Boehringer Ingelheim Investigational Site Sioux City Iowa
United States 1199.52.0106 Boehringer Ingelheim Investigational Site Sylvania Ohio
United States 1199.52.0104 Boehringer Ingelheim Investigational Site Topeka Kansas

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Russian Federation,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) by Central Review Assessment 22 months No
Primary Overall Survival (OS) by Central Review Assessment 22 months No
Secondary Objective Tumour Response (Complete Response + Partial Response) by Central Review Assessment 22 months No
Secondary Disease control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment 22 months No
See also
  Status Clinical Trial Phase
Recruiting NCT04552093 - Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT) Phase 2/Phase 3
Completed NCT04192565 - A Prospective Investigation of the ColubrisMX ELS System N/A
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Recruiting NCT03561350 - Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Recruiting NCT06128798 - Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery. N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Completed NCT03631407 - Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046) Phase 2
Withdrawn NCT04192929 - Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02889679 - Underwater Resection of Non-pedunculated Colorectal Lesions N/A
Terminated NCT02842580 - De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02564835 - Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02599103 - The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Completed NCT01669109 - Hatha Yoga for Patients With Colorectal Cancer N/A
Recruiting NCT01428752 - Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer N/A
Completed NCT01978717 - General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer N/A
Completed NCT01877018 - Colorectal Cancer Screening in Primary Care N/A
Terminated NCT00950820 - Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer Phase 2