Colorectal NeoplasmsPhase 2NCT02780700
Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]
A Phase 2 study testing Nintedanib and Capecitabine in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Nintedanib and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2016to 9 Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fort Wayne Medical Oncology Hematology
Fort Wayne, Indiana, 46845
About this study
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
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
- Conditions
- Colorectal Neoplasms
- Being tested
- Nintedanib, Capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
CapecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib | Experimental | Not described Receives: Drug: Nintedanib |
| Nintedanib plus capecitabine | Experimental | Not described Receives: Drug: Nintedanib; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Secondary outcomes (4)
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.
Measured: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
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.
Measured: tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.
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.
Measured: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Percentage of Patients With Grade 3 or Worse Adverse Events
Percentage of patients with grade 3 or worse adverse events.
Measured: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start5 Jul 2016
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
Why it stopped: Substance discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780700
- Sponsor's protocol ID
- 1199.251
- Status last verified
- Jan 2025
- First submitted
- 20 May 2016
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02780700
- Acronym / sponsor ID
- 1199.251
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Substance discontinued
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2016
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Posted 11 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib | Experimental | Drug: Nintedanib |
| Nintedanib plus capecitabine | Experimental | Drug: Nintedanib, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintedanib | Drug | Nintedanib, Nintedanib plus capecitabine |
| Capecitabine | Drug | Nintedanib plus capecitabine |
Primary outcome
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: 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.
Disease Control (DC)
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
Time frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nintedanib and Capecitabine in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Data collected up to cut-off date 09 Sep 2016, Up to 02 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.