Trials / Terminated
TerminatedNCT00955721
A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer
A Phase I/II Study of Combination of Gemcitabine, Oxaliplatin and Sorafenib (GEMOX-Sorafenib) in Patients With Advanced Biliary Tract Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.
Detailed description
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there are no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine | Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops. |
| DRUG | Oxaliplatin | Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops. |
| DRUG | Sorafenib | Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops. |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2009-08-10
- Last updated
- 2018-01-03
- Results posted
- 2015-02-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00955721. Inclusion in this directory is not an endorsement.