- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02780700
Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]
LUME-Colon 2: An Open-label Randomized Phase II Study to Assess the Efficacy and Safety of Nintedanib Alone or in Combination With Capecitabine for Patients With Refractory Metastatic Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46845
- Fort Wayne Medical Oncology Hematology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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 RECIST 1.1
- Previously treated with all of the following: fluoropyrimidine, (e.g. 5-fluorouracil (5-FU), capecitabine or TAS-102); oxaliplatin: Patients treated with oxaliplatin 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; Vascular Endothelial Growth Factor (VEGF) directed treatment (e.g. bevacizumab, aflibercept, ramucirumab or regorafenib); cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumors
- Minimal time interval of 3 weeks between the last administration of Colorectal Cancer (CRC) treatment (cytotoxics or targeted agents) and starting of trial therapy
- Adequate liver and kidney function
- Further inclusion criteria apply
Exclusion criteria:
- Prior treatment with nintedanib.
- Any other investigational agent received within 3 weeks prior to randomization
- Known hypersensitivity or intolerability to the trial drugs or their excipients
- History of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results. Patients with adequately treated basal or squamous cell skin cancer or cervix carcinoma and other early stage cancer treated curatively are eligible
- History of severe or unexpected reactions to fluoropyrimidine therapy or any of its excipients
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Treatment with sorivudine or its chemically related analogues, such as brivudine
- 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, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial
- Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion (signing Informed Consent), or planned surgical procedures during the trial period
- Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of myocardial infarction within past 6 months of trial inclusion, congestive heart failure > New York Heart Association (NYHA) II)
- History of severe hemorrhagic or thromboembolic event in the past 6 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis). Known inherited predisposition to bleeding or to thrombosis
- Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeuticInternational normalized ratio (INR) monitoring (treatment with low molecular weight heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device is allowed)
- Inflammatory bowel disease and other serious medical conditions increasing the risk of perforation or bleeding according to investigator's judgment
- Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug
- Patient with brain metastases that are symptomatic and/or require therapy. Patients with previously treated and stable brain metastases are allowed
- Further exclusion criteria apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nintedanib
|
|
Experimental: Nintedanib plus capecitabine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
PFS is defined as the time from randomization until objective tumor progression or death. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out. |
Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
Overall survival is defined as the time from randomization until death from any cause. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out. |
Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
Objective Response Rate (ORR)
Time Frame: tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.
|
ORR is defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out. |
tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.
|
Disease Control (DC)
Time Frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
Disease control is defined as CR or PR or Stable disease (SD) per RECIST version 1.1. Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out. |
Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
Percentage of Patients With Grade 3 or Worse Adverse Events
Time Frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
Percentage of patients with grade 3 or worse adverse events.
|
Data collected up to cut-off date 09 Sep 2016, Up to 02 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Capecitabine
- Nintedanib
Other Study ID Numbers
- 1199.251
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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