- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00355888
Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors
November 27, 2014 updated by: Mebiopharm Co., Ltd
A Phase I, Open Label Study of MBP-426 Given by Intravenous Infusion in Patients With Advanced or Metastatic Solid Tumors
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030-4009
- M.D. Anderson Cancer Center
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San Antonio, Texas, United States, 78245
- Institute for Drug Development
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Open label study of 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of dose-limiting toxicity, determination of maximum tolerated dose (MTD), and recommended Phase 2 dose
Time Frame: Within 21 days of treatment administration
|
Within 21 days of treatment administration
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor shrinkage according to RECIST
Time Frame: Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug
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Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug
|
Limited exploratory assays
Time Frame: Variable throughout study
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Variable throughout study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexandria Phan, M.D., M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
July 24, 2006
First Submitted That Met QC Criteria
July 24, 2006
First Posted (ESTIMATE)
July 25, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 27, 2014
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- M05-10070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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