CancerPhase 1NCT00355888
Safety Study of MBP-426 (Liposomal Oxaliplatin Suspension for Injection) to Treat Advanced or Metastatic Solid Tumors
A Phase 1 study testing MBP-426 in people with Cancer, run by Mebiopharm Co., Ltd at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- MBP-426
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M.D. Anderson Cancer Center
Houston, Texas, 77030-4009
Institute for Drug Development
San Antonio, Texas, 78245
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer
- Being tested
- MBP-426
- Keywords
- Cancer, Advanced or Metastatic Solid Tumor
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBP-426Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MBP-426 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity, determination of maximum tolerated dose (MTD), and recommended Phase 2 dose
Measured: Within 21 days of treatment administration
Secondary outcomes (2)
Tumor shrinkage according to RECIST
Measured: Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug
Limited exploratory assays
Measured: Variable throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mebiopharm Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandria Phan, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355888
- Sponsor's protocol ID
- M05-10070
- Status last verified
- Sep 2009
- First submitted
- 24 Jul 2006
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35048809
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study of MBP-426 Given by Intravenous Infusion in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT00355888
- Acronym / sponsor ID
- M05-10070
- Conditions
- Cancer
- Keywords
- Cancer, Advanced or Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mebiopharm Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label study of MBP-426 | Experimental | Drug: MBP-426Dose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Ability to cooperate with treatment and follow-up schedules
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBP-426Dose 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 | Open label study of MBP-426 |
Primary outcome
Incidence of dose-limiting toxicity, determination of maximum tolerated dose (MTD), and recommended Phase 2 dose
Time frame: Within 21 days of treatment administration
2 secondary outcomes
Tumor shrinkage according to RECIST
Time frame: Measured every 6 weeks (i.e., every 2 cycles) while receiving study drug
Limited exploratory assays
Time frame: Variable throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 35048809Alavi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandria Phan, M.D. principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MBP-426 in people with Cancer, run by Mebiopharm Co., Ltd at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00355888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.