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NCT02436135 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease

A Phase 1 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 1
Development phase
10
Enrollment target

NCT02436135: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.

NCT02436135 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02436135, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or post-ET MF) with progressive or relapsed disease. This is a dose-escalation study. There will be 4 cohorts (A, B, C, D). Participants will receive an escalating dose or dose frequency of idelalisib based on the safety data of available cohort(s).

Interventions

  • DRUG Ruxolitinib
  • DRUG Idelalisib

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2015-06-05
Est. Completion 2017-11-20
Phase Phase 1
Gilead Sciences

504 total trials

Why NCT02436135 stopped before completion

NCT02436135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Ruxolitinib is the first listed.

NCT02436135 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02436135 about?

NCT02436135 is a clinical study titled "Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Adults Receiving Ruxolitinib as Therapy for Primary, Post-Polycythemia Vera, or Post-Essential Thrombocythemia Myelofibrosis With Progressive or Relapsed Disease". The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of idelalisib in adults receiving ruxolitinib as therapy for intermediate to high-risk primary myelofibrosis (PMF), post-polycythemia vera, or post-essential thrombocythemia myelofibrosis (post-PV MF or...

What is the current status of trial NCT02436135?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-06-05. Estimated completion is 2017-11-20.

What interventions are being tested in trial NCT02436135?

The interventions under investigation include: Ruxolitinib (DRUG), Idelalisib (DRUG).

Who is sponsoring clinical trial NCT02436135?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02436135's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 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 NCT02436135, the US trial registry maintained by the National Library of Medicine. NCT02436135 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.