Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Nintedanib

Protein Kinase Inhibitors

Enzyme Inhibitors

Cola

Nintedanib (BIBF 1120)

Placebo

Boehringer Ingelheim

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.

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

A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.

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.

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.

Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.

Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).

1. patient who was randomised to the Placebo was not treated. Consequently, number of subjects that started is 382 but only 381 reported that includes only treated patients.
2. patients were randomised to the Nintedanib were not treated. Consequently, number of subjects that started is 386 but only 384 reported that includes only treated patients.

Placebo soft gelatin capsule matching that of Nintedanib twice daily (b.i.d.) administered orally of 21-day treatment course. If required the dose of placebo, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

Nintedanib 200 mg twice daily (b.i.d.) administered orally in the form of a soft gelatin capsule of 21-day treatment course. If required the dose of Nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

Total

Age, Continuous

Sex: Female, Male

Randomised Set (RS): This patient set included all patients who were randomised to receive treatment, whether treated or not.

Boehringer Ingelheim Call Center

Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.

Progression-Free Survival (PFS) by Central Review Assessment

Overall Survival (OS)

Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment

Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment

Overall Study

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Wounds and Injuries

Neoplasm Metastasis

Lung Neoplasms

Pneumonia

Radiation Pneumonitis

Communicable Diseases

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Lung Diseases, Interstitial

Lung Injury

Radiation Injuries

Anti-Inflammatory Agents

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

The initial dose of nintedanib will be 150mg two times per day orally according to study protocol. Nintedanib will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).

Placebo will be taken for 12 weeks. Patients will be given a prednisone taper (40mg prednisone daily for 2 weeks, followed by a strict dose taper of 10mg every 2 weeks for 4 weeks, followed by 10mg for one week and 5mg for one week, for a total duration on prednisone of 8 weeks).

Zachary Moore, MD

The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib in combination with steroids, has on the lungs. Furthermore, such treatments' side effects will be studied together with quality of life. In addition, the investigators would like to determine whether they can find markers in the blood which predict worsening lung injury.

Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis

Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis

An acute exacerbation will be defined as (all criteria must be met):

1. Unexplained worsening or development of cough, dyspnea, hypoxia, or pneumonitis lasting more than 4 days
2. New or worsening diffuse pulmonary infiltrates on chest CT (with or without contrast) or new high resolution CT parenchymal abnormalities without significant pneumothorax or pleural effusion

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)	NCT02149108	Colorectal Neop...	Nintedanib (BIB... Placebo BSC BSC	18 Years -	Boehringer Ingelheim
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis	NCT02496585	Lung Cancer Lung Metastases	Nintedanib Prednisone Placebo	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for nintedanib (bibf 1120)