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NCT01702285 · ClinicalTrials.gov registry record · Phase 1

Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Cancer Patients

A Phase 1 study, sponsored by Curis.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT01702285: Clinical Trial Phase 1 study, sponsored by Curis.

NCT01702285 is a Phase 1 study that was terminated before completion, run by Curis. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01702285, a Phase 1 study, was terminated before completion, sponsored by Curis.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

The main purpose of this study is to determine the safety and tolerability of orally administered CUDC-101 in cancer patients, and to determine a dose for further testing. This study will also determine how well CUDC-101 is absorbed into the blood after being given orally, assess CUDC-101 blood levels and what happens to the study drug in the body, and study how the body reacts to the study drug and what effects it has on tumors. CUDC-101 has been administered to cancer patients as an intravenous (IV) infusion in other research studies, but has not been studied when given orally.

Primary Outcome

The highest dose level studied at which fewer than 2 out of 6 subjects (\< 33%) experience a dose limiting toxicity (DLT).

Interventions

  • DRUG CUDC-101

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2012-09
Est. Completion 2012-12
Phase Phase 1
Curis

12 total trials

Why NCT01702285 stopped before completion

NCT01702285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

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

NCT01702285 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01702285 about?

NCT01702285 is a clinical study titled "Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Orally Administered CUDC-101 in Cancer Patients". The main purpose of this study is to determine the safety and tolerability of orally administered CUDC-101 in cancer patients, and to determine a dose for further testing. This study will also determine how well CUDC-101 is absorbed into the blood after being given orally, assess CUDC-101 blood leve...

What is the current status of trial NCT01702285?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2012-09. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01702285?

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

Who is sponsoring clinical trial NCT01702285?

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

How this trial's enrollment target compares

Where NCT01702285's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 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 NCT01702285, the US trial registry maintained by the National Library of Medicine. NCT01702285 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.