Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]
Primary Purpose
Colorectal Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nintedanib
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
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
Sites / Locations
- Fort Wayne Medical Oncology Hematology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nintedanib
Nintedanib plus capecitabine
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
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.
Secondary Outcome Measures
Overall Survival (OS)
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.
Objective Response Rate (ORR)
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.
Disease Control (DC)
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.
Percentage of Patients With Grade 3 or Worse Adverse Events
Percentage of patients with grade 3 or worse adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02780700
Brief Title
Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Substance discontinued
Study Start Date
July 5, 2016 (undefined)
Primary Completion Date
September 9, 2016 (Actual)
Study Completion Date
September 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The objective of this Phase II study is to assess the efficacy and safety of nintedanib alone or in combination with capecitabine for patients with refractory metastatic colorectal cancer (mCRC) after failure of at least 2 lines of standard treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nintedanib
Arm Type
Experimental
Arm Title
Nintedanib plus capecitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.
Title
Disease Control (DC)
Description
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.
Time Frame
Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Title
Percentage of Patients With Grade 3 or Worse Adverse Events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Fort Wayne Medical Oncology Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]
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