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NCT01459614 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01459614 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 44 participants.
The verdict
NCT01459614, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Primary Objectives To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month. Secondary Objectives * To assess safety and characterize toxicities of the combination of GTX with cisplatin in subjects with metastatic pancreatic cancer. * To estimate disease control rate (DCR), PFS, and overall survival (OS). * To estimate a PFS rate of an expansion cohort testing an alternative schedule. Study Design This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be enrolled, 28 in the initial cohort and 10 in the expansion cohort The study will have a safety run-in phase consisting of 6 subjects. To ensure that the combination is safe, the first six subjects will be treated at DL1 and observed for limiting toxicity for the first 2 cycles before continuation with further accrual. After the safety run-in, the study will be continuously monitored for adverse events. The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of subjects alive, free of disease progression at 6 months. The treatment regimen would be considered of insufficient activity for further study in this population if PFS rate at 6 months is 50% or less, and the minimum required level of efficacy that would warrant further study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes interim monitoring for futility using a predictive probability approach. We will stop the study early if given the information at the interim analysis, it is unlikely that the PFS rate at 6 months will be greater than 50% if the study continues to the end.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Taxotere
- DRUG Xeloda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01459614
The ClinicalTrials.gov registry entry for NCT01459614 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT01459614 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01459614 about?
NCT01459614 is a clinical study titled "Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer". Primary Objectives To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month. Secondary Objectives * To assess safety and characterize toxicities of...
What is the current status of trial NCT01459614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2011-11. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01459614?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Taxotere (DRUG), Xeloda (DRUG).
Who is sponsoring clinical trial NCT01459614?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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