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NCT02451553 · ClinicalTrials.gov registry record · Phase 1
Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer
A Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 2
- Study locations
NCT02451553: Completed Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, sponsored by University of Washington.
NCT02451553 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm that has completed, run by University of Washington. The registered enrollment target is 41 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02451553, a Phase 1 study of Advanced Malignant Solid Neoplasm and Recurrent Malignant Solid Neoplasm, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Adverse events will be tabulated and summarized by dose levels. Summary tabulations will be presented displaying the number of observations, mean, standard deviation, median, minimum, and maximum for continuous variables, and the number and percentage per category for categorical data. Toxicity measurement will be accompanied by 90% confidence intervals.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2015-11-05 |
| Est. Completion | 2022-04-16 |
| Phase | Phase 1 |
What the finished NCT02451553 record still lists
NCT02451553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (77% lower).
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.
NCT02451553 reports a single indexed study location in Indiana, Washington.
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.
What interventions are being tested in trial NCT02451553?
The interventions under investigation include: Capecitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Afatinib Dimaleate (DRUG).
Who is sponsoring clinical trial NCT02451553?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02451553's enrollment target sits among peer trials
41 60th of 108 higher than 49 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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