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NCT02599324 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors

A Phase 1 study, sponsored by Pharmacyclics.

Completed
Registry status
Phase 1
Development phase
263
Enrollment target

NCT02599324: Completed Phase 1 study, sponsored by Pharmacyclics.

NCT02599324 is a Phase 1 study that has completed, run by Pharmacyclics. The registered enrollment target is 263 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (338% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02599324, a Phase 1 study, has completed, sponsored by Pharmacyclics.

COMPLETED
Registry status
Phase 1
Development phase
263 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advance gastrointestinal and genitourinary tumors.

Primary Outcome

A DLT was defined as any Grade 3 (severe) or higher non-hematologic or Grade 4 (life-threatening) hematologic adverse event (AE) occurring during the DLT observation period that was considered to be at least possibly related to the study treatment (ibrutinib or drug combination).

Interventions

  • DRUG cetuximab
  • DRUG docetaxel
  • DRUG paclitaxel
  • DRUG ibrutinib
  • DRUG everolimus

Trial Details

FieldValue
Enrollment Target 263 participants
Start Date 2015-12-01
Est. Completion 2021-08-20
Phase Phase 1
Pharmacyclics

54 total trials

What the finished NCT02599324 record still lists

NCT02599324 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (338% higher).

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

NCT02599324 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02599324 about?

NCT02599324 is a clinical study titled "Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary Tumors". The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advance gastrointestinal and genitourinary tumors.

What is the current status of trial NCT02599324?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 263 participants. The study started on 2015-12-01. Estimated completion is 2021-08-20.

What interventions are being tested in trial NCT02599324?

The interventions under investigation include: cetuximab (DRUG), docetaxel (DRUG), paclitaxel (DRUG), ibrutinib (DRUG), everolimus (DRUG).

Who is sponsoring clinical trial NCT02599324?

This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02599324's enrollment target sits among peer trials

263 158th of 2000 higher than 1,842 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 NCT02599324, the US trial registry maintained by the National Library of Medicine. NCT02599324 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.