Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01355302 · ClinicalTrials.gov registry record · Phase 1
E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer
A Phase 1 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01355302: Clinical Trial Phase 1 study, sponsored by Eisai.
NCT01355302 is a Phase 1 study that was terminated before completion, run by Eisai. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01355302, a Phase 1 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and capecitabine is more effective in patients with previously untreated gastric cancer versus cisplatin and capecitabine alone.
Primary Outcome
On days when pharmacokinetic (PK) samples were to be drawn, a predose blood sample was obtained prior to administration of golvatinib and capecitabine. After administration of study drugs, a second postdose blood sample was taken. The amount of golvatinib in the participant's blood was analyzed and the AUC was calculated. The AUC reflects the actual body exposure to drug after administration of a dose of the drug and is dependent on the rate of elimination of the drug from the body and the dose
Interventions
- DRUG cisplatin
- DRUG capecitabine
- DRUG E7050
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
Why NCT01355302 stopped before completion
NCT01355302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which cisplatin is the first listed.
NCT01355302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01355302 about?
NCT01355302 is a clinical study titled "E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer". The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and capecitabine is more effective in...
What is the current status of trial NCT01355302?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2011-11. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01355302?
The interventions under investigation include: cisplatin (DRUG), capecitabine (DRUG), E7050 (DRUG).
Who is sponsoring clinical trial NCT01355302?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01355302's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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 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