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NCT01171924 · ClinicalTrials.gov registry record · Phase 1

A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors

A Phase 1 study, sponsored by Curis.

Completed
Registry status
Phase 1
Development phase
47
Enrollment target

NCT01171924 is a Phase 1 study that has completed, run by Curis. The registered enrollment target is 47 participants.

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The verdict

NCT01171924, a Phase 1 study, has completed, sponsored by Curis.

COMPLETED
Registry status
Phase 1
Development phase
47 participants
Enrollment target

Study Summary

This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer 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 compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.

Interventions

  • DRUG CUDC-101

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2010-07
Est. Completion 2011-10
Phase Phase 1

Sponsor

Curis

12 total trials

What the Registry Record Tells You About NCT01171924

The ClinicalTrials.gov registry entry for NCT01171924 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Curis, which has 12 total studies on file at ClinicalTrials.gov.

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

NCT01171924 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01171924 about?

NCT01171924 is a clinical study titled "A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors". This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Ty...

What is the current status of trial NCT01171924?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2010-07. Estimated completion is 2011-10.

What interventions are being tested in trial NCT01171924?

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

Who is sponsoring clinical trial NCT01171924?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.