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NCT01290471 · ClinicalTrials.gov registry record · Phase 1

Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors

A Phase 1 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT01290471: Completed Phase 1 study, sponsored by Daiichi Sankyo.

NCT01290471 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01290471, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

This is a Phase 1, open label study to assess the safety and tolerability of U3 1565, determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety and tolerability.

Primary Outcome

Number (percent) of subjects experiencing adverse events (AEs) after treatment with U3-1565

Interventions

  • DRUG U3-1565

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2011-01
Est. Completion 2013-01
Phase Phase 1
Daiichi Sankyo

236 total trials

What the finished NCT01290471 record still lists

NCT01290471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 1 intervention - of which U3-1565 is the first listed.

NCT01290471 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01290471 about?

NCT01290471 is a clinical study titled "Study to Assess the Safety and Tolerability of U3-1565 in Subjects With Advanced Solid Malignant Tumors". This is a Phase 1, open label study to assess the safety and tolerability of U3 1565, determine maximum tolerated dose (MTD) or establish maximum administered dose (MAD) safety and tolerability.

What is the current status of trial NCT01290471?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-01. Estimated completion is 2013-01.

What interventions are being tested in trial NCT01290471?

The interventions under investigation include: U3-1565 (DRUG).

Who is sponsoring clinical trial NCT01290471?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01290471's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 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 NCT01290471, the US trial registry maintained by the National Library of Medicine. NCT01290471 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.