CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 47 enrolled
Drug / intervention
CUDC-101 +1 moredrug
Likely dose
CUDC-101 275 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01171924
NCT01171924Phase 1Completed
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A Phase Ib Open Label, Expansion Study to Investigate 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

Curis, Inc.·interventional·Posted Jul 29, 2010·Updated Mar 1, 2016

In Brief

A Phase 1 clinical trial evaluating CUDC-101 for Head and Neck Cancer and 4 related conditions. Completed, enrolled 47 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Liver Cancer, Breast Cancer, Gastric Cancer, Non-Small Cell Lung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2010
Enrollment StartJul 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.9 years ago

Interventions

CUDC-101drug

CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.

CUDC-101drug

CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.