Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT00964080

Run by

Mebiopharm Co., Ltd

People needed

62

Starts

2009-05-01

Expected to finish

2015-04-01

Last updated by the study team

2014-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase Ib:
• Advanced or metastatic solid tumor malignancy that is refractory to STD therapy, or that has relapsed after STD therapy, or for which conventional therapy is not reliably effective, or no effective therapy is available.
• Measurable disease as defined by RECIST. If recurrence is documented following radiation therapy, the recurrence must have occurred outside the radiation field. Lesions which are located within a previously irradiated field are not considered measurable.
• Age ≥18.
• ECOG performance status: 0, 1 or 2.
• Adequate organ and system function:
• Bone marrow: ANC ≥1500/mm3, platelet count ≥100000/mm3, and Hb ≥9 g/dL;
• Coagulation: PT <1.3 x ULN, PTT >LLN, <1.1 x ULN
• Renal: Serum creatinine of ≤1.5 x the institution's ULN or calculated creatinine clearance ≥60 mL/min/1.73m2;
• Hepatic: Total bilirubin ≤1.5 mg/dL, ALT and AST ≤2.5 x ULN (or 5 x ULN), and ALP ≤2.5 x ULN (or 5 x ULN).
• Recovered to ≤Gr 1 from all acute toxicities caused by prior cancer therapies except for residual toxicities which do not pose an ongoing medical risk.
• If of childbearing potential, agree to use an effective method of contraception prior to study entry, for the duration of the study, and for 30 days after the last dose of MBP-426 with FA/5-FU. A negative pregnancy test must be documented at baseline. Patients may not breastfeed while in this study.
• Have the ability to maintain a central IV access.
• Able to comply with the protocol treatments and procedures.
• Provide written informed consent indicating that they are aware of the investigational nature of this study and in keeping with the institution's policies.
• Phase II:
• Inoperable, histologically, or cytologically confirmed, locally advanced or metastatic gastric, GE junction, or esophageal adenocarcinoma that has recurred or progressed following 1 prior chemotherapy.
• Measurable disease as defined by RECIST. If recurrence is documented following radiation therapy, the recurrence must have occurred outside the radiation field. Lesions which are located within a previously irradiated field are not considered measurable.
• ECOG performance status: 0 or 1.
• Identical to criteria numbers 3-10 for Phase Ib portion of the study.
• Exclusion Criteria (Phase Ib and II):
• Major surgery within 14 days prior to study enrollment.
• Radiotherapy, hormonal therapy, immunotherapy, or investigational agents within 30 days of enrollment (6 weeks for mitomycin C). A washout is required for chemotherapy, antibodies and small molecules, equivalent to at least 5 half-lives or 30 days, whichever is shorter, prior to study entry. Concurrent use of bisphosphonates is permitted.
• Have had a past or have a current 2nd primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin, or other malignancy treated at least 3 years previously with surgery and/or radiotherapy and no evidence of recurrence since that time).
• Known or clinical evidence of CNS metastases.

Where it is running

• Mary Crowley Medical Research Center — Dallas, Texas, United States
• MD Anderson — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• A.Gvamichava National Center of Cancer — Tbilisi, Georgia
• Medulla Chemotherapy and Immunotherapy Clinic — Tbilisi, Georgia

Full record on ClinicalTrials.gov

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