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| Sponsor: | Mebiopharm Co., Ltd |
|---|---|
| Collaborator: |
AAIPharma |
| Information provided by: | Mebiopharm Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT00964080 |
Purpose
This will be a Phase Ib/II, open-label, non-randomized, single arm study of MBP-426. MBP-426 will be administered every 21 days as an intravenous (IV) infusion at a starting dose of 226 mg/m2, in combination with leucovorin (folinic acid or FA) and 5 fluorouracil (FU). Following MBP-426 administration, leucovorin (400 mg/m2) will be administered IV with an IV bolus of 400 mg/m2 fluorouracil (on the same day as MBP 426), followed by 2400 mg/m2 fluorouracil continuous IV (CIV) infusion over 46 hours. Patients will be premedicated 15 minutes prior to MBP-426 infusion with 10 mg dexamethasone (IV), 8 mg Zofran®, and 25 mg Benadryl®.
In the Phase Ib portion of this study, the first cohort of patients will receive MBP-426 at a dose of 226 mg/m2. Subsequent patients will be treated at doses in accordance with the table below. The dose for the Phase II study will be determined based on the toxicity seen in the Phase Ib patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Adenocarcinoma Gastroesophageal Adenocarcinoma Esophageal Adenocarcinoma |
Drug: MBP426/Leucovorin/5-FU |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase Ib/II Study of MBP-426 in Patients With Second Line Gastric, Gastro Esophageal, or Esophageal Adenocarcinoma |
| Estimated Enrollment: | 62 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
MBP426/Leucovorin/5-FU: Experimental
MBP-426 infusion rate will start at 75 mL/hr for 15 minutes, will increase to 100 mL/hr for the next 15 minutes, and then increase to a maximum of 150 mL/hr for the remainder of the study drug administration, as tolerated. Leucovorin is to be administered at a dose of 400 mg/m² as a 2-hour infusion on Day 1, repeated every 3 weeks. Leucovorin administration will be administered immediately after the MBP-426 infusion, in the absence of allergy/infusion reaction. Leucovorin will be administered concurrently with 5-FU administration. 5-FU is administered as a bolus of 400 mg/m² over 5-15 minutes, beginning concurrently with the leucovorin infusion, after the MBP-426 administration on Day 1. This is followed by a 46-hour continuous infusion of 2400 mg/m² 5-FU. These infusions (bolus and continuous) are to be repeated every 3 weeks. |
Drug: MBP426/Leucovorin/5-FU
MBP-426 (30 mL vials, 24 mg of MBP-426). MBP-426 infusion rate will start at 75 mL/hr for 15 minutes, will increase to 100 mL/hr for the next 15 minutes, and then increase to a maximum of 150 mL/hr for the remainder of the study drug administration. Leucovorin is to be administered at a dose of 400 mg/m² as a 2-hour infusion on Day 1, repeated every 3 weeks. Leucovorin administration will be administered immediately after the MBP-426 infusion, in the absence of allergy/infusion reaction. Leucovorin will be administered concurrently with 5-FU administration. 5-FU is administered as a bolus of 400 mg/m² over 5-15 minutes, beginning concurrently with the leucovorin infusion, after the MBP-426 administration on Day 1. This is followed by a 46-hour continuous infusion of 2400 mg/m² 5-FU. These infusions (bolus and continuous) are to be repeated every 3 weeks. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Phase Ib:
Adequate organ and system function defined by the following parameters:
Phase II:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Mary Crowley Medical Research Center | Recruiting |
| Dallas, Texas, United States, 76201 | |
| Contact: Neil Senzer, MD 214-658-1952 nsenzer@marycrowley.org | |
| Contact: Alyssa Roth 972-566-3061 aroth@marycrowley.org | |
| Principal Investigator: Neil N Senzer, MD | |
More Information
| Responsible Party: | Mebiopharm Co., Ltd. ( Nobuyuki Yamagata/ Project Management & Business Development Dept. ) |
| Study ID Numbers: | MBP-426 201 |
| Study First Received: | August 17, 2009 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00964080 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Vitamin B Complex Neoplasms by Histologic Type Digestive System Neoplasms Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Leucovorin Pharmacologic Actions Carcinoma Neoplasms |
Digestive System Diseases Neoplasms by Site Stomach Diseases Vitamins Stomach Neoplasms Gastrointestinal Neoplasms Micronutrients Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |