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| Sponsor: | Mebiopharm Co., Ltd |
|---|---|
| Information provided by: | Mebiopharm Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT00964080 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Adenocarcinoma Gastroesophageal Adenocarcinoma Esophageal Adenocarcinoma |
Drug: MBP426/Leucovorin/5-FU |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: MBP426/Leucovorin/5-FU |
Drug: MBP426/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.
|
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: Staci Horvath 214-658-1937 shorvath@marycrowley.org | |
| Principal Investigator: Neil N Senzer, MD | |
| MD Anderson | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jaffer Ajani, MD 713-792-2828 jajani@mdanderson.org | |
| Contact: Silva Bell 713-792-4748 sbell@mdanderson.org | |
| Principal Investigator: Jaffer Ajani, MD | |
| United States, Utah | |
| Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Marelene Mitchell 801-587-4779 marlene.mitchell@hci.utah.edu | |
| Contact: Triny Cooper 801-585-3800 triny.cooper@hci.utah.edu | |
| Principal Investigator: Sunil Sharma, MD | |
More Information
| Responsible Party: | Kazuhiko Matsuno/ Director of Clinical Development and Preclinical, Mebiopharm Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00964080 History of Changes |
| Other Study ID Numbers: | MBP-426 201 |
| Study First Received: | August 17, 2009 |
| Last Updated: | February 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Adenocarcinoma Esophageal Diseases Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Stomach Diseases Fluorouracil Leucovorin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |