Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Curis.
NCT01171924 is a Phase 1 study that has completed, run by Curis. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
Interventions
- DRUG CUDC-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01171924 record still lists
NCT01171924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 1 intervention - of which CUDC-101 is the first listed.
NCT01171924 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01171924's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03313011 · 47 participants
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
- NCT03467516 · 47 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
- NCT03886662 · 47 participants · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
- NCT04013802 · 47 participants · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia