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NCT01926587 · ClinicalTrials.gov registry record · Phase 1

Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine

A Phase 1 study, sponsored by Traws Pharma.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target

NCT01926587: Completed Phase 1 study, sponsored by Traws Pharma.

NCT01926587 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01926587, a Phase 1 study, has completed, sponsored by Traws Pharma.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target

Study Summary

This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety of patients is an objective throughout all parts of the study.

Primary Outcome

Dose Limiting Toxicity is defined as Grade 3 or greater non-hematological toxicity or stomatitis and/or esophagitis/dysphagitis lasting longer than 3 days.

Interventions

  • DRUG Azacitidine
  • DRUG oral rigosertib

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2013-08
Est. Completion 2021-02-16
Phase Phase 1
Traws Pharma

25 total trials

What the finished NCT01926587 record still lists

NCT01926587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

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

NCT01926587 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01926587 about?

NCT01926587 is a clinical study titled "Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine". This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has meas...

What is the current status of trial NCT01926587?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2013-08. Estimated completion is 2021-02-16.

What interventions are being tested in trial NCT01926587?

The interventions under investigation include: Azacitidine (DRUG), oral rigosertib (DRUG).

Who is sponsoring clinical trial NCT01926587?

This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01926587's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 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 NCT01926587, the US trial registry maintained by the National Library of Medicine. NCT01926587 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.