Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Capecitabine

Nintedanib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Cola

Boehringer Ingelheim

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

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

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.

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.

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 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.

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

Nintedanib Plus Capecitabine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Treated set (TS): This will comprise all patients who are randomized and are documented to have taken at least one dose of trial medication

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.

Boehringer IIngelheim, Call Center

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

Spots Global Cancer Trial Database for Nintedanib Alone or in Combination With Capecitabine in Refractory Metastatic Colorectal Cancer [LUME-Colon 2]

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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