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NCT00728793 · ClinicalTrials.gov registry record · Phase 1

A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Curis.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT00728793: Completed Phase 1 study, sponsored by Curis.

NCT00728793 is a Phase 1 study that has completed, run by Curis. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00728793, a Phase 1 study, has completed, sponsored by Curis.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, including the maximum tolerated dose, the pharmacokinetics, and the anti-tumor activity of CUDC-101.

Primary Outcome

The maximum tolerated dose is the highest dose level at which \<33% of at least 6 or more subjects experiences a dose limiting toxicity.

Interventions

  • DRUG CUDC-101

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2008-08
Est. Completion 2010-04
Phase Phase 1
Curis

12 total trials

What the finished NCT00728793 record still lists

NCT00728793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 1 intervention - of which CUDC-101 is the first listed.

NCT00728793 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00728793 about?

NCT00728793 is a clinical study titled "A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors". This is a phase I, open-label, dose-escalation study of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2(Her2) and histone deacetylase (HDAC). ...

What is the current status of trial NCT00728793?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2008-08. Estimated completion is 2010-04.

What interventions are being tested in trial NCT00728793?

The interventions under investigation include: CUDC-101 (DRUG).

Who is sponsoring clinical trial NCT00728793?

This trial is sponsored by Curis, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00728793's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 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 NCT00728793, the US trial registry maintained by the National Library of Medicine. NCT00728793 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.