Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors
NCT ID: NCT00355888
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2006-06-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Mebiopharm Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Alexandria Phan, M.D.
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M.D. Anderson Cancer Center
Houston, Texas, United States
Institute for Drug Development
San Antonio, Texas, United States
Countries
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References
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Alavi N, Rezaei M, Maghami P, Fanipakdel A, Avan A. Nanocarrier System for Increasing the Therapeutic Efficacy of Oxaliplatin. Curr Cancer Drug Targets. 2022;22(5):361-372. doi: 10.2174/1568009622666220120115140.
Other Identifiers
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M05-10070
Identifier Type: -
Identifier Source: org_study_id