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

NCT00355888 | Completed Phase 1

• 1 other identifier: M05-10070
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer; Advanced or Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (1)

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

  Within 21 days of treatment administration

Secondary Outcomes (2)

• Tumor shrinkage according to RECIST

  Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug

• Limited exploratory assays

  Variable throughout study

Study Arms (1)

Open label study of MBP-426

EXPERIMENTAL

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.

Drug: MBP-426

Interventions

MBP-426 DRUG

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.

Open label study of MBP-426

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mebiopharm Co., Ltd: lead

Study Sites (2)

M.D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Institute for Drug Development

San Antonio, Texas, 78245, United States

Location

Related Publications (1)

• 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.

  PMID: 35048809 DERIVED

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandria Phan, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: June 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: April 1, 2009
• Last Updated: December 2, 2014

Record last verified: 2009-09

Locations

US (2)