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Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2] | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT02780700•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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)
+5 more criteria

Locations (1)

Fort Wayne Medical Oncology Hematology

Fort Wayne, Indiana, United States

Key Dates

Start Date

July 5, 2016

Primary Completion Date

September 9, 2016

Completion Date

September 9, 2016

Last Updated

February 3, 2025

Enrollment

ACTUAL participants

Conditions

Colorectal Neoplasms

Interventions

Nintedanib

DRUG

Capecitabine

DRUG

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NCT06662786

Colorectal Neoplasms

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RECRUITINGPHASE1

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Colorectal NeoplasmsGastrointestinal Neoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]

Inclusion Criteria

Exclusion Criteria

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

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Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer

Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.