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NCT01395537 · ClinicalTrials.gov registry record · Phase 1
Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ)
A Phase 1 study, sponsored by Case Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01395537: Clinical Trial Phase 1 study, sponsored by Case Comprehensive Cancer Center.
NCT01395537 is a Phase 1 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01395537, a Phase 1 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent for the treatment of esophageal and GEJ tumors. PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in combination with capecitabine or letrozole. It is hoped that by giving lapatinib and carboplatin and paclitaxel together, their combined effects will further slow or stop the cancer cells from growing.
Primary Outcome
A dose limiting toxicity (DLT) will be defined as any grade 3-4 non-hematologic toxicity or increase in bilirubin \>/= 2 mg/dL (\>2X baseline in patients with Gilbert's syndrome), or elevation in AST/ALT \> 3.0 X ULN during the first 3 week course of therapy.
Interventions
- DRUG Paclitaxel
- DRUG lapatinib
- DRUG Carboplatin AUC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Why NCT01395537 stopped before completion
NCT01395537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Paclitaxel is the first listed.
NCT01395537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01395537 about?
NCT01395537 is a clinical study titled "Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ)". RATIONALE: Since lapatinib inhibits both EGFR and HER2 receptors, it is an attractive agent for the treatment of esophageal and GEJ tumors. PURPOSE: Lapatinib is currently approved for HER2 positive metastatic breast cancer in combination with capecitabine or letrozole. It is hoped that by giving l...
What is the current status of trial NCT01395537?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01395537?
The interventions under investigation include: Paclitaxel (DRUG), lapatinib (DRUG), Carboplatin AUC (DRUG).
Who is sponsoring clinical trial NCT01395537?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01395537's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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