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NCT02193958 · ClinicalTrials.gov registry record · Phase 1

Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies

A Phase 1 study, sponsored by Fujifilm Pharmaceuticals U.S.A..

Completed
Registry status
Phase 1
Development phase
55
Enrollment target

NCT02193958: Completed Phase 1 study, sponsored by Fujifilm Pharmaceuticals U.S.A..

NCT02193958 is a Phase 1 study that has completed, run by Fujifilm Pharmaceuticals U.S.A.. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02193958, a Phase 1 study, has completed, sponsored by Fujifilm Pharmaceuticals U.S.A..

COMPLETED
Registry status
Phase 1
Development phase
55 participants
Enrollment target

Study Summary

A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.

Primary Outcome

Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity

Interventions

  • DRUG FF-10501-01

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2014-07
Est. Completion 2019-10-15
Phase Phase 1
Fujifilm Pharmaceuticals U.S.A.

8 total trials

What the finished NCT02193958 record still lists

NCT02193958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which FF-10501-01 is the first listed.

NCT02193958 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02193958 about?

NCT02193958 is a clinical study titled "Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies". A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML treated at the RP2D are planned, ...

What is the current status of trial NCT02193958?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2014-07. Estimated completion is 2019-10-15.

What interventions are being tested in trial NCT02193958?

The interventions under investigation include: FF-10501-01 (DRUG).

Who is sponsoring clinical trial NCT02193958?

This trial is sponsored by Fujifilm Pharmaceuticals U.S.A., which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02193958's enrollment target sits among peer trials

55 918th of 2000 higher than 1,070 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 NCT02193958, the US trial registry maintained by the National Library of Medicine. NCT02193958 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.