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

Phase 2

Terminated

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Nintedanib; Drug: Capecitabine

• Registration Number: NCT02780700
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-23
• Study Start: 2016-07-05
• Primary Completion: 2016-09-09
• Study Completion: 2016-09-09
• Results First Submitted: 2018-08-02
• Results First Submitted QC: 2018-09-12
• Results First Posted: 2018-10-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nintedanib plus capecitabine	Nintedanib	-
Nintedanib	Nintedanib	-
Nintedanib plus capecitabine	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Data collected up to cut-off date 09 Sep 2016, Up to 02 months	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)	tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.	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)	Data collected up to cut-off date 09 Sep 2016, Up to 02 months	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	Data collected up to cut-off date 09 Sep 2016, Up to 02 months	Percentage of patients with grade 3 or worse adverse events.

Trial Locations

Locations (1)

Fort Wayne Medical Oncology Hematology; 🇺🇸 Fort Wayne, Indiana, United States