Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors - Full Text View

Sponsor:	Mebiopharm Co., Ltd
Information provided by:	Mebiopharm Co., Ltd
ClinicalTrials.gov Identifier:	NCT00355888

Purpose

The purpose of this study is to determine whether MBP-426 (liposomal oxaliplatin suspension for injection) is safe and effective in the treatment of advanced or metastatic solid tumors.

Condition	Intervention	Phase
Cancer	Drug: MBP-426	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Mebiopharm Co., Ltd:

Primary Outcome Measures:

Incidence of dose-limiting toxicity, determination of maximum tolerated dose (MTD), and recommended Phase 2 dose [ Time Frame: Within 21 days of treatment administration ] [ Designated as safety issue: Yes ]
Limited pharmacokinetics [ Time Frame: During Cycles 1 and 2; possibly at end of study, if necessary ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor shrinkage according to RECIST [ Time Frame: Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug ] [ Designated as safety issue: No ]
Limited exploratory assays [ Time Frame: Variable throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2006
Study Completion Date:	April 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: MBP-426 Dose escalation starting at 6 mg/m2, IV (in the vein) on Day 1 of each 21-day cycle. Number of Cycles: Up to 6 cycles, until unacceptable toxicity, disease progression, or intercurrent illness requires treatment discontinuation. Patients may continue treatment beyond 6 cycles if the Investigator determines that additional treatment would provide further benefit for the patient as long as toxicity remains acceptable.

Arms

Assigned Interventions

Experimental: 1

Drug: MBP-426

Dose escalation starting at 6 mg/m2, IV (in the vein) on Day 1 of each 21-day cycle. Number of Cycles: Up to 6 cycles, until unacceptable toxicity, disease progression, or intercurrent illness requires treatment discontinuation. Patients may continue treatment beyond 6 cycles if the Investigator determines that additional treatment would provide further benefit for the patient as long as toxicity remains acceptable.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355888

Locations

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Institute for Drug Development
San Antonio, Texas, United States, 78245

Sponsors and Collaborators

Mebiopharm Co., Ltd

Investigators

Principal Investigator:

Alexandria Phan, M.D.

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	Margaret Valnoski, President, Theradex, Inc.
ClinicalTrials.gov Identifier:	NCT00355888 History of Changes
Other Study ID Numbers:	M05-10070
Study First Received:	July 24, 2006
Last Updated:	September 15, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mebiopharm Co., Ltd:

Cancer
Advanced or Metastatic Solid Tumor

ClinicalTrials.gov processed this record on February 09, 2012