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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02780700
• Other study ID #: 1199.251
• Status: Terminated
• Phase: Phase 2
• Start date: July 5, 2016
• Est. completion date: September 9, 2016

Study information

• Verified date: September 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 9, 2016
• Est. primary completion date: September 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Nintedanib

• Capecitabine

Locations

Country	Name	City	State
United States	Fort Wayne Medical Oncology Hematology	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Secondary	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.	tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.
Secondary	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.	Data collected up to cut-off date 09 Sep 2016, Up to 02 months
Secondary	Percentage of Patients With Grade 3 or Worse Adverse Events	Percentage of patients with grade 3 or worse adverse events.	Data collected up to cut-off date 09 Sep 2016, Up to 02 months

External Links

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