Trial Outcomes & Findings for Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2] (NCT NCT02780700)

Last Updated: 2025-02-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

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

Results posted on

2025-02-03

Participant Flow

This was an exploratory, phase II multi-center, non-comparative, open-label, randomized trial to assess the efficacy and safety of nintedanib alone, or in combination with capecitabine in patients with refractory metastatic colorectal cancer.

Patients eligible for this study were to be randomized in a 1:1 fashion to receive either nintedanib alone or combination with capecitabine. One patient with combination therapy entered study, no patient with nintedanib alone entered study.

Participant milestones

Participant milestones
Measure	Nintedanib Plus Capecitabine Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nintedanib Plus Capecitabine Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Overall Study Progressive disease	1

Baseline Characteristics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nintedanib Plus Capecitabine n=1 Participants Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Age, Continuous	50 years STANDARD_DEVIATION NA • n=5 Participants • TS
Sex: Female, Male Female	1 Participants n=5 Participants • TS
Sex: Female, Male Male	0 Participants n=5 Participants • TS
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants • TS
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants • TS
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • TS
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • TS
Race (NIH/OMB) Asian	0 Participants n=5 Participants • TS
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • TS
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • TS
Race (NIH/OMB) White	1 Participants n=5 Participants • TS
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • TS
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • TS

PRIMARY outcome

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

Population: Randomized set (RS): Comprising all patients who have a randomization date recorded in the electronic Case record form (eCRF).

Outcome measures

Outcome measures
Measure	Nintedanib Plus Capecitabine n=1 Participants Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Progression Free Survival (PFS)	NA months Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.

SECONDARY outcome

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

Population: RS

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.

Outcome measures

Outcome measures
Measure	Nintedanib Plus Capecitabine n=1 Participants Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Overall Survival (OS)	NA months Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.

SECONDARY outcome

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

Population: RS

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.

Outcome measures

Outcome measures
Measure	Nintedanib Plus Capecitabine n=1 Participants Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Objective Response Rate (ORR)	NA Percentage of participants Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.

SECONDARY outcome

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

Population: RS

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.

Outcome measures

Outcome measures
Measure	Nintedanib Plus Capecitabine n=1 Participants Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Disease Control (DC)	NA Percentage of participants Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out.

SECONDARY outcome

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

Population: RS

Percentage of patients with grade 3 or worse adverse events.

Outcome measures

Outcome measures
Measure	Nintedanib Plus Capecitabine n=1 Participants Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Percentage of Patients With Grade 3 or Worse Adverse Events	0 Percentage of participants

Adverse Events

Nintedanib Plus Capecitabine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nintedanib Plus Capecitabine n=1 participants at risk Patients were to be orally administered tablets of Nintedanib and 1000 mg/m2 Capecitabine twice daily. Nintedanib: 21 day cycles; Capecitabine: first 14 days of each 21 day cycle
Metabolism and nutrition disorders Decreased appetite	100.0% 1/1 • From first drug administration till end of trial; up to 3 months
General disorders Fatigue	100.0% 1/1 • From first drug administration till end of trial; up to 3 months

Additional Information

Boehringer IIngelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place