Trials / Unknown
UnknownNCT00964080
Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma
A Phase Ib/II Study of MBP-426 in Patients With Second Line Gastric, Gastro Esophageal, or Esophageal Adenocarcinoma
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- Sponsor
- Mebiopharm Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The ongoing study is a Phase II, open-label study to evaluate the efficacy of MBP-426 at a dose of 170 mg/m2 in combination therapy in patients with second line metastatic gastric, gastro-esophageal junction or esophageal adenocarcinoma.
Detailed description
This study will start with a Phase Ib portion, at a dose of 226 mg/m2, a dose in which good tolerability was demonstrated in the Phase I trial. A cohort may be enrolled at 301 mg/m2, if 226 mg/m2 is well tolerated. The dose determined from the Phase Ib portion of the study will then be evaluated in the Phase II portion. This design will permit evaluation of a true positive or negative response while limiting over exposure of patients to the study drug. If this regimen does offer a positive response, its reduced toxicity and potentially greater efficacy may yield better outcomes for patients requiring second-line therapy for UGI cancer. Following completion of the Phase Ib part of the present trial, the dose recommended for use in the Phase II part is 170 mg/m2 MBP-426.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MBP-426/Leucovorin/5-FU | MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered at a dose of 400 mg/m2 after the MBP-426 infusion and in the absence of allergy/infusion reaction. 5-FU is administered concurrently with the leucovorin infusion and after the MBP-426 administration as a 46-hour continuous infusion of 2400 mg/m2. |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2012-10-01
- Completion
- 2015-04-01
- First posted
- 2009-08-24
- Last updated
- 2014-12-02
Locations
5 sites across 2 countries: United States, Georgia
Source: ClinicalTrials.gov record NCT00964080. Inclusion in this directory is not an endorsement.