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COMPLETED Phase 1

Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer

NCT02393755 · View on ClinicalTrials.gov ↗

Study Summary

This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine may be a better treatment for colorectal cancer.

Interventions

  • DRUG Capecitabine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Nintedanib
  • OTHER Pharmacological Study

Study Locations (2)

California

  • City of Hope Comprehensive Cancer Center — Duarte

New York

  • Roswell Park Cancer Institute — Buffalo

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2015-05-08
Est. Completion 2021-05-18
Phase Phase 1

Sponsor

Roswell Park Cancer Institute

228 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02393755

The ClinicalTrials.gov registry entry for NCT02393755 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 228 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Rectal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02393755 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02393755 about?

NCT02393755 is a clinical study titled "Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer". This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic)...

What is the current status of trial NCT02393755?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2015-05-08. Estimated completion is 2021-05-18.

What conditions does trial NCT02393755 study?

This clinical trial studies the following conditions: Rectal Adenocarcinoma, Colon Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage IVA Colon Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02393755?

The interventions under investigation include: Capecitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Nintedanib (DRUG), Pharmacological Study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02393755?

This trial is sponsored by Roswell Park Cancer Institute, which has 228 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02393755 being conducted?

This trial has 2 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial