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A Phase I, Open Label Study of MBP-426 Given by Intravenous Infusion in Patients With Advanced or Metastatic Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I, Open Label Study of MBP-426 Given by Intravenous Infusion in Patients With Advanced or Metastatic Solid Tumors

Study Phase 1 Study Type (Interventional/Observational) Interventional Study Design
Purpose: Treatment Allocation: Nonrandomized trial Masking: Open Control: Dose Comparison
Assignment: Single Group Endpoint: Safety/Efficacy

Inclusion Criteria:

- Pathologically-confirmed malignancy that is locally advanced or metastatic solid
tumor and is refractory to standard therapy or for which conventional therapy is not
reliably effective or no effective therapy is available

- 18 years of age or older

- ECOG Performance Status of 0, 1, or 2

- Adequate clinical laboratory values:

- absolute neutrophil count greater than or equal to 1500 cells/microliter

- platelets greater than or equal to 100,000 cells/microliter

- serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) for the

- creatinine clearance (calculated) > 60 mL/min (using the Cockcroft-Gault

- bilirubin less than or equal to 1.5 x ULN

- alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal
to 2.5 x ULN (patients with known liver metastases may have up to 5 times ULN
AST and ALT levels).

- Ability to cooperate with treatment and follow-up schedules

- Negative pregnancy test and using at least one form of contraception as approved by
the Investigator prior to study entry if a female patient of childbearing potential
or a male patient with a female partner of childbearing potential

- Measurable disease as defined by RECIST criteria or non-measurable disease

- Patients with known brain metastases may be included as long as they have been
clinically stable for one month or more, and are not receiving dexamethasone

- Ability to maintain a central intravenous access (e.g. PICC, Groshong, or Hickman

- Signed informed consent prior to the start of any study specific procedures

Exclusion Criteria:

- Received previous anticancer chemotherapy, immunotherapy, radiotherapy or any other
investigational therapy in the 4 weeks (6 weeks for nitrosoureas or mitomycin C)
prior to study entry

- Received extensive prior radiotherapy to more than 30% of bone marrow reserves, or
prior bone marrow/stem cell transplantation

- Any concomitant condition that could compromise the objectives of this study and the
patient's compliance

- Pregnant or lactating women

- Current malignancies of another type, with the exception of adequately treated in
situ cervical cancer and basal cell skin cancer or have demonstrated no evidence of
disease for 5 years or more

- Clinically evident HIV, HBV, or HCV infection

- Hematologic malignancy

- Documented or known bleeding disorder

- Requirements for therapeutic anticoagulation that increases INR or aPTT above the
normal range (low dose deep vein thrombosis [DVT] or line prophylaxis is allowed)

- Congestive heart failure

- Greater than Grade 1 peripheral neuropathy according to the National Cancer
Institute's Common Terminology Criteria for Adverse Events v3.0 (CTCAE version 3.0)

- History of allergic reactions to platinum-based or liposomal agents

- Creatinine clearance (calculated) less than or equal to 60 mL/min (using the
Cockcroft-Gault equation)

- Receiving or initiating treatment with any other investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of dose-limiting toxicity, determination of maximum tolerated dose (MTD), and recommended Phase 2 dose

Outcome Time Frame:

Within 21 days of treatment administration

Safety Issue:


Principal Investigator

Alexandria Phan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

April 2009

Related Keywords:

  • Cancer
  • Cancer
  • Advanced or Metastatic Solid Tumor



Institute for Drug DevelopmentSan Antonio, Texas  78245-3217
M.D. Anderson Cancer CenterHouston, Texas  77030