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NCT01219023 · ClinicalTrials.gov registry record · Phase 1
Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil
A Phase 1 study of Palmar-plantar Erythrodysesthesia and Hand Foot Syndrome, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01219023: Completed Phase 1 study of Palmar-plantar Erythrodysesthesia and Hand Foot Syndrome, sponsored by Duke University.
NCT01219023 is a Phase 1 study of Palmar-plantar Erythrodysesthesia and Hand Foot Syndrome that has completed, run by Duke University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01219023, a Phase 1 study of Palmar-plantar Erythrodysesthesia and Hand Foot Syndrome, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a 25%-50% of patients treated with several commonly used anti-cancer drugs including capecitabine and sunitinib. These drugs are known to improve survival in many cancers, including cancers of the colon, stomach, liver, breast, kidney, and GI stromal tumors (GIST). Worldwide, over 400,000 patients per year are treated with one of these agents. HFS involves skin changes, such as swelling, peeling, and blistering of the palms and soles, which is often painful and debilitating. As a result, HFS-related symptoms can frequently lead to dose reduction and/or discontinuation of otherwise effective anti-cancer treatment. There is no treatment for HFS other than dose reduction or stopping treatment. This proposal could quickly lead to treatments to prevent and/or treat HFS and help patients avoid debilitating side effects while continuing otherwise effective treatments for their cancer.
Primary Outcome
Grading of PPE by NCI CTC criteria occurs every 2 weeks for subjects in the sunitinib arm for 1st 8 weeks (and as clinically indicated). Grading of PPE by NCI CTC criteria occurs every 3 weeks for subjects in the capeccitabine arm for the 1st 9 weeks (and as clinically indicated)
Conditions Studied
Interventions
- DRUG sildenafil citrate
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01219023 record still lists
NCT01219023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Palmar-plantar Erythrodysesthesia appearing as the primary indexed condition, and to 1 intervention - of which sildenafil citrate is the first listed.
NCT01219023 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01219023 about?
NCT01219023 is a clinical study titled "Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil". Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a 25%-50% of patients treated with several commonly used anti-cancer drugs including capecitabine and sunitinib. These drugs are known to improve survival in many cancers, including cancers of the colon, stomac...
What is the current status of trial NCT01219023?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-06. Estimated completion is 2012-04.
What conditions does trial NCT01219023 study?
This clinical trial studies the following conditions: Palmar-plantar Erythrodysesthesia, Hand Foot Syndrome.
What interventions are being tested in trial NCT01219023?
The interventions under investigation include: sildenafil citrate (DRUG).
Who is sponsoring clinical trial NCT01219023?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01219023 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01219023's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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