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A Phase Ib/II Study of MBP-426 in Patients With Second Line Gastric, Gastro Esophageal, or Esophageal Adenocarcinoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma

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Trial Information

A Phase Ib/II Study of MBP-426 in Patients With Second Line Gastric, Gastro Esophageal, or Esophageal Adenocarcinoma


Inclusion Criteria:



Phase Ib:

1. Advanced or metastatic solid tumor malignancy that is refractory to standard therapy,
or that has relapsed after standard therapy, or for which conventional therapy is not
reliably effective, or no effective therapy is available.

2. 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.

3. Age 18 years or older.

4. ECOG performance status of 0, 1 or 2.

5. Adequate organ and system function defined by the following parameters:

- Bone marrow: Absolute neutrophil count (ANC) of >=1500/mm3, platelet count
>=100,000/mm3, and hemoglobin >=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 upper limit of normal (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 in the
case of liver metastases), and alkaline phosphatase <=2.5 x ULN (or 5 x ULN in
the case of liver metastases).

6. Recovered to <=Grade 1 from all acute toxicities caused by prior cancer therapies
except for residual toxicities, such as alopecia, which do not pose an ongoing
medical risk.

7. 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 (in combination with FA/5-FU). A negative serum or urine pregnancy test must
be documented at baseline for women of childbearing potential. Patients may not
breastfeed while in this study.

8. Have the ability to maintain a central IV access.

9. Able to comply with the protocol treatments and procedures.

10. Provide written informed consent indicating that they are aware of the
investigational nature of this study and in keeping with the policies of the
institution.

Phase II:

1. Inoperable, histologically, or cytologically confirmed, locally advanced or
metastatic gastric, gastro-esophageal junction, or esophageal adenocarcinoma that has
recurred or progressed following 1 prior chemotherapy.

2. 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.

3. ECOG performance status of 0 or 1.

4. Identical to criteria numbers 3-10 for Phase Ib portion of the study.

Exclusion Criteria:

1. Major surgery within 14 days prior to study enrollment.

2. Radiotherapy, hormonal therapy, immunotherapy, or investigational agents within 30
days of enrollment (6 weeks for mitomycin C). A washout period 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.

3. Have had a past or have a current second 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).

4. Known or clinical evidence of CNS metastases.

5. Receiving high-dose steroids (more than a dexamethasone-equivalent dose of 4 mg per
day).

6. Current active infections requiring anti-infectious treatment (e.g., antibiotics,
antivirals, or antifungals).

7. Significant intercurrent illnesses that, in the opinion of the Investigator, would
have compromise the safety of the patient or compromise the ability of the patient to
complete the study.

8. Documented or known hematologic malignancy and/or bleeding disorder.

9. Peripheral neuropathy >= grade 2 (NCI-CTCAE, Version 3.0).

10. Any requirement(s) for therapeutic anticoagulation that increases INR or aPTT above
the normal range (low dose deep vein thrombosis [DVT] or line prophylaxis is
allowed).

11. Have New York Heart Association (NYHA) Class 3 or 4 heart disease, active ischemia,
or any uncontrolled, unstable cardiac condition for which treatment for the condition
is indicated but is not controlled despite adequate therapy including angina
pectoris, cardiac arrhythmia, hypertension, or congestive heart failure.

12. History of allergy to any of the treatment components (oxaliplatin, 5-FU, folinic
acid, liposome, ferritin).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

4 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MBP-426 201

NCT ID:

NCT00964080

Start Date:

May 2009

Completion Date:

March 2013

Related Keywords:

  • Gastric Adenocarcinoma
  • Gastroesophageal Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Stomach Neoplasms

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112
Mary Crowley Medical Research CenterDallas, Texas  75246
MD AndersonHouston, Texas  77230