Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00964080|
Recruitment Status : Unknown
Verified April 2012 by Mebiopharm Co., Ltd.
Recruitment status was: Active, not recruiting
First Posted : August 24, 2009
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Esophageal Adenocarcinoma||Drug: MBP-426/Leucovorin/5-FU||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of MBP-426 in Patients With Second Line Gastric, Gastro Esophageal, or Esophageal Adenocarcinoma|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||April 2015|
Experimental: Study of MBP-426/leucovorin/5-FU
Study of MBP-426/leucovorin/5-FU. MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered ata 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.
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.
Other Name: Liposomal Oxaliplatin/Folinic Acid/5-Fluorouracil
- To determine the dose of MBP-426 for use in the Phase II portion of this study of MBP-426 administered every 21 days in combination with leucovorin (folinic acid or FA) and fluorouracil (5-FU) [ Time Frame: 4 months ]
- To characterize the safety profile of the combination therapy [ Time Frame: 4 months ]
- To determine the plasma and urine pharmacokinetics of MBP-426 when given in combination with leucovorin and 5-FU [ Time Frame: 4 months ]
- To undertake a preliminary exploration of anti-tumor activity of the combination therapy [ Time Frame: 4 months ]
- To characterize the safety profile of the combination therapy [ Time Frame: 16 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964080
|United States, Texas|
|Mary Crowley Medical Research Center|
|Dallas, Texas, United States, 76201|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|A.Gvamichava National Center of Cancer|
|Tbilisi, Georgia, 0177|
|Medulla Chemotherapy and Immunotherapy Clinic|
|Tbilisi, Georgia, 0186|
|Principal Investigator:||Jaffer A. Ajani, MD||UT MD Anderson Cancer Center|