| July 24, 2006 |
| September 15, 2009 |
| June 2006 |
| November 2008 (final data collection date for primary outcome measure) |
- 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 ]
|
| Incidence of dose-limiting toxicity within 21 days of treatment administration; determination of maximum tolerated dose (MTD) and recommended Phase 2 dose; limited pharmacokinetics |
| Complete list of historical versions of study NCT00355888 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Tumor shrinkage according to RECIST criteria, measured every 6 weeks (i.e., every 2 cycles) while receiving study drug; limited exploratory assays |
| |
| Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors |
| 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 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 |
| Phase I |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Cancer |
| Drug: MBP-426 |
| |
| |
| |
| Completed |
| 30 |
| April 2009 |
| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00355888 |
| Margaret Valnoski, President, Theradex, Inc. |
| M05-10070 |
| Mebiopharm Co., Ltd |
|
| Principal Investigator: |
Alexandria Phan, M.D. |
M.D. Anderson Cancer Center |
|
|
| Mebiopharm Co., Ltd |
| September 2009 |