Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)

Phase 3

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Nintedanib (BIBF 1120); Drug: Placebo; Drug: BSC

• Registration Number: NCT02149108
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-29
• Study Start: 2014-09-25
• Primary Completion: 2016-05-13
• Study Completion: 2016-08-25
• Results First Submitted: 2017-05-08
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-23
• Last Update Submitted: 2017-06-23
• Results First Posted: 2017-07-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 768

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nintedanib (BIBF 1120) + BSC	Nintedanib (BIBF 1120)	-
Nintedanib (BIBF 1120) + BSC	BSC	-
Placebo + BSC	Placebo	-
Placebo + BSC	BSC	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) by Central Review Assessment	From randomisation until cut-off date 14JUN2016.	PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first.; Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Overall Survival (OS)	From randomisation until cut-off date 14JUN2016.	OS was defined as the time from randomisation to the time of death from any cause.; Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.

Secondary Outcome Measures

Name	Time	Method
Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment	From randomisation until cut-off date 14JUN2016.	Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).
Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment	From randomisation until cut-off date 14JUN2016.	Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.

Trial Locations

Locations (129)

1199.52.3505 Boehringer Ingelheim Investigational Site; 🇵🇹 Loures, Portugal

1199.52.3204 Boehringer Ingelheim Investigational Site; 🇧🇪 Edegem, Belgium

1199.52.0108 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1199.52.0113 Boehringer Ingelheim Investigational Site; 🇺🇸 Detroit, Michigan, United States

1199.52.0114 Boehringer Ingelheim Investigational Site; 🇺🇸 New Orleans, Louisiana, United States

1199.52.3205 Boehringer Ingelheim Investigational Site; 🇧🇪 Bonheiden, Belgium

1199.52.0125 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

1199.52.3207 Boehringer Ingelheim Investigational Site; 🇧🇪 Charleroi, Belgium

1199.52.3521 Boehringer Ingelheim Investigational Site; 🇧🇪 Luxembourg, Belgium

1199.52.4201 Boehringer Ingelheim Investigational Site; 🇨🇿 Prague, Czechia

1199.52.3307 Boehringer Ingelheim Investigational Site; 🇫🇷 Lyon cedex 8, France

1199.52.0106 Boehringer Ingelheim Investigational Site; 🇺🇸 Sylvania, Ohio, United States

1199.52.0105 Boehringer Ingelheim Investigational Site; 🇺🇸 New Haven, Connecticut, United States

1199.52.4302 Boehringer Ingelheim Investigational Site; 🇦🇹 Linz, Austria

1199.52.4905 Boehringer Ingelheim Investigational Site; 🇩🇪 Essen, Germany

1199.52.1002 Boehringer Ingelheim Investigational Site; 🇨🇦 Montreal, Quebec, Canada

1199.52.1004 Boehringer Ingelheim Investigational Site; 🇨🇦 Edmonton, Ontario, Canada

1199.52.0104 Boehringer Ingelheim Investigational Site; 🇺🇸 Topeka, Kansas, United States

1199.52.0123 Boehringer Ingelheim Investigational Site; 🇺🇸 Sioux City, Iowa, United States

1199.52.6105 Boehringer Ingelheim Investigational Site; 🇦🇺 Nedlands, Western Australia, Australia

1199.52.3208 Boehringer Ingelheim Investigational Site; 🇧🇪 Aalst, Belgium

1199.52.5403 Boehringer Ingelheim Investigational Site; 🇦🇷 Ciudad Autónoma de Bs As, Argentina

1199.52.4202 Boehringer Ingelheim Investigational Site; 🇨🇿 Brno, Czechia

1199.52.4303 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1199.52.8115 Boehringer Ingelheim Investigational Site; 🇯🇵 Hyogo, Amagasaki, Japan

1199.52.8110 Boehringer Ingelheim Investigational Site; 🇯🇵 Oita, Yufu, Japan

1199.52.4501 Boehringer Ingelheim Investigational Site; 🇩🇰 København Ø, Denmark

1199.52.4503 Boehringer Ingelheim Investigational Site; 🇩🇰 Næstved, Denmark

1199.52.9004 Boehringer Ingelheim Investigational Site; 🇹🇷 Istanbul, Turkey

1199.52.1001 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1199.52.4401 Boehringer Ingelheim Investigational Site; 🇬🇧 Aberdeen, United Kingdom

1199.52.3305 Boehringer Ingelheim Investigational Site; 🇫🇷 Paris cedex 15, France

1199.52.0707 Boehringer Ingelheim Investigational Site; 🇷🇺 Tyumen, Russian Federation

1199.52.0121 Boehringer Ingelheim Investigational Site; 🇺🇸 Arlington Heights, Illinois, United States

1199.52.0101 Boehringer Ingelheim Investigational Site; 🇺🇸 Plainville, Connecticut, United States

1199.52.3905 Boehringer Ingelheim Investigational Site; 🇮🇹 Padova, Italy

1199.52.0115 Boehringer Ingelheim Investigational Site; 🇺🇸 Canton, Ohio, United States

1199.52.0119 Boehringer Ingelheim Investigational Site; 🇺🇸 Johnson City, New York, United States

1199.52.0120 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Worth, Texas, United States

1199.52.0102 Boehringer Ingelheim Investigational Site; 🇺🇸 Nashville, Tennessee, United States

1199.52.5401 Boehringer Ingelheim Investigational Site; 🇦🇷 Ciudad Autónoma de Bs As, Argentina

1199.52.5404 Boehringer Ingelheim Investigational Site; 🇦🇷 Cdad. de Córdoba, Argentina

1199.52.5405 Boehringer Ingelheim Investigational Site; 🇦🇷 Cdad. de Córdoba, Argentina

1199.52.6102 Boehringer Ingelheim Investigational Site; 🇦🇺 Concord, New South Wales, Australia

1199.52.8101 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiba, Kashiwa, Japan

1199.52.5406 Boehringer Ingelheim Investigational Site; 🇦🇷 Ciudad Autónoma de Bs As, Argentina

1199.52.6103 Boehringer Ingelheim Investigational Site; 🇦🇺 St Leonards, New South Wales, Australia

1199.52.6101 Boehringer Ingelheim Investigational Site; 🇦🇺 Wollongong, New South Wales, Australia

1199.52.6104 Boehringer Ingelheim Investigational Site; 🇦🇺 Heidelberg, Victoria, Australia

1199.52.3202 Boehringer Ingelheim Investigational Site; 🇧🇪 Bruxelles, Belgium

1199.52.4304 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1199.52.3201 Boehringer Ingelheim Investigational Site; 🇧🇪 Leuven, Belgium

1199.52.3206 Boehringer Ingelheim Investigational Site; 🇧🇪 Liège, Belgium

1199.52.4204 Boehringer Ingelheim Investigational Site; 🇨🇿 Hradec Kralove, Czechia

1199.52.4502 Boehringer Ingelheim Investigational Site; 🇩🇰 Herning, Denmark

1199.52.4504 Boehringer Ingelheim Investigational Site; 🇩🇰 Odense C, Denmark

1199.52.3304 Boehringer Ingelheim Investigational Site; 🇫🇷 Lille cedex, France

1199.52.3301 Boehringer Ingelheim Investigational Site; 🇫🇷 Reims Cedex, France

1199.52.4906 Boehringer Ingelheim Investigational Site; 🇩🇪 Dresden, Germany

1199.52.4903 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany

1199.52.4904 Boehringer Ingelheim Investigational Site; 🇩🇪 Freiburg, Germany

1199.52.4901 Boehringer Ingelheim Investigational Site; 🇩🇪 Ulm, Germany

1199.52.8501 Boehringer Ingelheim Investigational Site; 🇭🇰 Hong Kong, Hong Kong

1199.52.9706 Boehringer Ingelheim Investigational Site; 🇮🇱 Beer Sheva, Israel

1199.52.9704 Boehringer Ingelheim Investigational Site; 🇮🇱 Petach Tikva, Israel

1199.52.3901 Boehringer Ingelheim Investigational Site; 🇮🇹 Genova, Italy

1199.52.9703 Boehringer Ingelheim Investigational Site; 🇮🇱 Tel Aviv, Israel

1199.52.3906 Boehringer Ingelheim Investigational Site; 🇮🇹 Milano, Italy

1199.52.3903 Boehringer Ingelheim Investigational Site; 🇮🇹 Pisa, Italy

1199.52.3907 Boehringer Ingelheim Investigational Site; 🇮🇹 Napoli, Italy

1199.52.3904 Boehringer Ingelheim Investigational Site; 🇮🇹 San Giovanni Rotondo (FG), Italy

1199.52.8102 Boehringer Ingelheim Investigational Site; 🇯🇵 Aichi, Nagoya, Japan

1199.52.8105 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiba, Chiba, Japan

1199.52.8108 Boehringer Ingelheim Investigational Site; 🇯🇵 Hokkaido, Sapporo, Japan

1199.52.8107 Boehringer Ingelheim Investigational Site; 🇯🇵 Ehime, Matsuyama, Japan

1199.52.8106 Boehringer Ingelheim Investigational Site; 🇯🇵 Fukuoka, Fukuoka, Japan

1199.52.8112 Boehringer Ingelheim Investigational Site; 🇯🇵 Hyogo, Kobe, Japan

1199.52.8116 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1199.52.8114 Boehringer Ingelheim Investigational Site; 🇯🇵 Ibaraki, Tsukuba, Japan

1199.52.8113 Boehringer Ingelheim Investigational Site; 🇯🇵 Tokyo , Shinagawa-ku, Japan

1199.52.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1199.52.8204 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1199.52.8103 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Suita, Japan

1199.52.8104 Boehringer Ingelheim Investigational Site; 🇯🇵 Shizuoka, Sunto-gun, Japan

1199.52.8109 Boehringer Ingelheim Investigational Site; 🇯🇵 Saitama, Kitaadachi-gun, Japan

1199.52.8111 Boehringer Ingelheim Investigational Site; 🇯🇵 Tokyo, Koto-ku, Japan

1199.52.8202 Boehringer Ingelheim Investigational Site; 🇰🇷 Goyang, Korea, Republic of

1199.52.5201 Boehringer Ingelheim Investigational Site; 🇲🇽 Mexico, Mexico

1199.52.8203 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1199.52.3103 Boehringer Ingelheim Investigational Site; 🇳🇱 Amsterdam, Netherlands

1199.52.3101 Boehringer Ingelheim Investigational Site; 🇳🇱 Amsterdam, Netherlands

1199.52.3102 Boehringer Ingelheim Investigational Site; 🇳🇱 Utrecht, Netherlands

1199.52.4803 Boehringer Ingelheim Investigational Site; 🇵🇱 Poznan, Poland

1199.52.4801 Boehringer Ingelheim Investigational Site; 🇵🇱 Jelenia Gora, Poland

1199.52.4804 Boehringer Ingelheim Investigational Site; 🇵🇱 Wroclaw, Poland

1199.52.3504 Boehringer Ingelheim Investigational Site; 🇵🇹 Almada, Portugal

1199.52.3501 Boehringer Ingelheim Investigational Site; 🇵🇹 Porto, Portugal

1199.52.3502 Boehringer Ingelheim Investigational Site; 🇵🇹 Coimbra, Portugal

1199.52.0701 Boehringer Ingelheim Investigational Site; 🇷🇺 Moscow, Russian Federation

1199.52.3506 Boehringer Ingelheim Investigational Site; 🇵🇹 Porto, Portugal

1199.52.0702 Boehringer Ingelheim Investigational Site; 🇷🇺 St. Petersburg, Russian Federation

1199.52.0703 Boehringer Ingelheim Investigational Site; 🇷🇺 Moscow, Russian Federation

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

1199.52.3404 Boehringer Ingelheim Investigational Site; 🇪🇸 Madrid, Spain

1199.52.3403 Boehringer Ingelheim Investigational Site; 🇪🇸 Madrid, Spain

1199.52.3407 Boehringer Ingelheim Investigational Site; 🇪🇸 Sevilla, Spain

1199.52.4601 Boehringer Ingelheim Investigational Site; 🇸🇪 Stockholm, Sweden

1199.52.4602 Boehringer Ingelheim Investigational Site; 🇸🇪 Uppsala, Sweden

1199.52.3405 Boehringer Ingelheim Investigational Site; 🇪🇸 Santander, Spain

1199.52.8801 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

1199.52.8805 Boehringer Ingelheim Investigational Site; 🇨🇳 Kaohsiung, Taiwan

1199.52.8802 Boehringer Ingelheim Investigational Site; 🇨🇳 Taoyuan County, Taiwan

1199.52.8803 Boehringer Ingelheim Investigational Site; 🇨🇳 Taipei, Taiwan

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

1199.52.9002 Boehringer Ingelheim Investigational Site; 🇹🇷 Izmir, Turkey

1199.52.4402 Boehringer Ingelheim Investigational Site; 🇬🇧 Middlesex, United Kingdom

1199.52.4403 Boehringer Ingelheim Investigational Site; 🇬🇧 Manchester, United Kingdom

1199.52.4405 Boehringer Ingelheim Investigational Site; 🇬🇧 Nottingham, United Kingdom

1199.52.4404 Boehringer Ingelheim Investigational Site; 🇬🇧 Southampton, United Kingdom

1199.52.1003 Boehringer Ingelheim Investigational Site; 🇨🇦 Vancouver, British Columbia, Canada

1199.52.3203 Boehringer Ingelheim Investigational Site; 🇧🇪 Haine-Saint-Paul, Belgium

1199.52.6106 Boehringer Ingelheim Investigational Site; 🇦🇺 Perth, Western Australia, Australia

1199.52.8504 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