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NCT02394535 · ClinicalTrials.gov registry record · Phase 1

Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients With Locally Advanced Pancreatic Cancer

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT02394535: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT02394535 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02394535, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of nab-paclitaxel when given together with capecitabine and radiation therapy following first treatment with chemotherapy (induction therapy) in treating patients with pancreatic cancer that is not spread to tissue far away but is not operable due to abutment or encasement of blood vessels nearby (locally advanced). Drugs used in chemotherapy, such as nab-paclitaxel and 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, capecitabine, and radiation therapy together may kill more tumor cells.

Primary Outcome

Descriptive statistics will be used to summarize will be used to summarize patient demographic and clinical characteristics as well as the incidence of DLTs at each dose level.

Interventions

  • DRUG Capecitabine
  • OTHER Laboratory Biomarker Analysis
  • OTHER Questionnaire Administration
  • RADIATION Radiation Therapy
  • DRUG Nab-paclitaxel

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2015-11-12
Est. Completion 2022-08-31
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02394535 record still lists

NCT02394535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.

NCT02394535 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02394535 about?

NCT02394535 is a clinical study titled "Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients With Locally Advanced Pancreatic Cancer". This phase I trial studies the side effects and best dose of nab-paclitaxel when given together with capecitabine and radiation therapy following first treatment with chemotherapy (induction therapy) in treating patients with pancreatic cancer that is not spread to tissue far away but is not operabl...

What is the current status of trial NCT02394535?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2015-11-12. Estimated completion is 2022-08-31.

What interventions are being tested in trial NCT02394535?

The interventions under investigation include: Capecitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Radiation Therapy (RADIATION), Nab-paclitaxel (DRUG).

Who is sponsoring clinical trial NCT02394535?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02394535's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02394535, the US trial registry maintained by the National Library of Medicine. NCT02394535 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.