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

NCT02780700 | Terminated Phase 2 Results

• 1 other identifier: 1199.251
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  Data collected up to cut-off date 09 Sep 2016, Up to 02 months

Secondary Outcomes (4)

• Overall Survival (OS)

  Data collected up to cut-off date 09 Sep 2016, Up to 02 months

• Objective Response Rate (ORR)

  tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.

• Disease Control (DC)

  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

Study Arms (2)

Nintedanib

EXPERIMENTAL

Drug: Nintedanib

Nintedanib plus capecitabine

EXPERIMENTAL

Drug: Nintedanib; Drug: Capecitabine

Interventions

Nintedanib DRUG

Nintedanib; Nintedanib plus capecitabine

Capecitabine DRUG

Nintedanib plus capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Fort Wayne Medical Oncology Hematology

Fort Wayne, Indiana, 46845, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

nintedanib; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Trial was terminated prematurely because it was determined that nintedanib monotherapy demonstrated lack of efficacy in this indication in pivotal Phase III trial (LUME-Colon 1) that was ongoing at the time of the initiation of this trial.

Results Point of Contact

• Title: Boehringer IIngelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 23, 2016
• Study Start: July 5, 2016
• Primary Completion: September 9, 2016
• Study Completion: September 9, 2016
• Last Updated: February 3, 2025
• Results First Posted: October 11, 2018

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)