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COMPLETED Phase 1

Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer

NCT02451553 · View on ClinicalTrials.gov ↗

Study Summary

This phase I/Ib trial studies the side effects and best dose of afatinib dimaleate when given together with capecitabine in treating patients with solid tumors, pancreatic cancer, or biliary cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment and has not responded to previous treatment. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell 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 afatinib dimaleate together with capecitabine may be a better treatment for solid tumors, pancreatic cancer, or biliary cancer.

Interventions

  • DRUG Capecitabine
  • OTHER Laboratory Biomarker Analysis
  • DRUG Afatinib Dimaleate

Study Locations (2)

Indiana

  • Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis

Washington

  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2015-11-05
Est. Completion 2022-04-16
Phase Phase 1

Sponsor

University of Washington

987 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02451553

The ClinicalTrials.gov registry entry for NCT02451553 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 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 987 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 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: NCT02451553 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Indiana, Washington. 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 NCT02451553 about?

NCT02451553 is a clinical study titled "Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer". This phase I/Ib trial studies the side effects and best dose of afatinib dimaleate when given together with capecitabine in treating patients with solid tumors, pancreatic cancer, or biliary cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment a...

What is the current status of trial NCT02451553?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2015-11-05. Estimated completion is 2022-04-16.

What conditions does trial NCT02451553 study?

This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer AJCC v6 and v7, Bile Duct Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02451553?

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

Who is sponsoring clinical trial NCT02451553?

This trial is sponsored by University of Washington, which has 987 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02451553 being conducted?

This trial has 2 study locations across Indiana, Washington. 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