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NCT06445959 · ClinicalTrials.gov registry record · Phase 1

Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib

A Phase 1 study of Mutant IDH1 Inhibitor Olutasidenib, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
78
Enrollment target
1
Study location

NCT06445959: Recruiting Phase 1 study of Mutant IDH1 Inhibitor Olutasidenib, sponsored by M.D. Anderson Cancer Center.

NCT06445959 is a Phase 1 study of Mutant IDH1 Inhibitor Olutasidenib that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06445959, a Phase 1 study of Mutant IDH1 Inhibitor Olutasidenib, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
78 participants
Enrollment target
1
Study location

Study Summary

To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.

Primary Outcome

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Interventions

  • DRUG Venetoclax
  • DRUG Decitabine
  • DRUG Olutasidenib
  • DRUG Decitabine/cedazuridine

Study Locations (1)

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2024-08-29
Est. Completion 2029-06-30
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What NCT06445959 shows while recruiting

NCT06445959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).

The record links to 1 condition, with Mutant IDH1 Inhibitor Olutasidenib appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.

NCT06445959 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06445959 about?

NCT06445959 is a clinical study titled "Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib". To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.

What is the current status of trial NCT06445959?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2024-08-29. Estimated completion is 2029-06-30.

What conditions does trial NCT06445959 study?

This clinical trial studies the following conditions: Mutant IDH1 Inhibitor Olutasidenib.

What interventions are being tested in trial NCT06445959?

The interventions under investigation include: Venetoclax (DRUG), Decitabine (DRUG), Olutasidenib (DRUG), Decitabine/cedazuridine (DRUG).

Who is sponsoring clinical trial NCT06445959?

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

Where is trial NCT06445959 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06445959's enrollment target sits among peer trials

78 697th of 2000 higher than 1,298 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 NCT06445959, the US trial registry maintained by the National Library of Medicine. NCT06445959 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.