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Gastric AdenocarcinomaPhase 1/2NCT00964080

Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma

A Phase 1/2 study testing MBP-426/Leucovorin/5-FU in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Mebiopharm Co., Ltd at 5 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The ongoing study is a Phase II, open-label study to evaluate the efficacy of MBP-426 at a dose of 170 mg/m2 in combination therapy in patients with second line metastatic gastric, gastro-esophageal junction or esophageal adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MBP-426/Leucovorin/5-FU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
5 sitesin 2 countries
Study dates
May 2009to Apr 2015
Phase
Phase 1/2
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

  • Phase Ib:
  • Advanced or metastatic solid tumor malignancy that is refractory to STD therapy, or that has relapsed after STD therapy, or for which conventional therapy is not reliably effective, or no effective therapy is available.
  • Measurable disease as defined by RECIST. If recurrence is documented following radiation therapy, the recurrence must have occurred outside the radiation field. Lesions which are located within a previously irradiated field are not considered measurable.
  • Age ≥18.
  • ECOG performance status: 0, 1 or 2.
  • Adequate organ and system function:
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  • Bone marrow: ANC ≥1500/mm3, platelet count ≥100000/mm3, and Hb ≥9 g/dL;
  • Coagulation: PT <1.3 x ULN, PTT >LLN, <1.1 x ULN
  • Renal: Serum creatinine of ≤1.5 x the institution's ULN or calculated creatinine clearance ≥60 mL/min/1.73m2;
  • Hepatic: Total bilirubin ≤1.5 mg/dL, ALT and AST ≤2.5 x ULN (or 5 x ULN), and ALP ≤2.5 x ULN (or 5 x ULN).
  • Recovered to ≤Gr 1 from all acute toxicities caused by prior cancer therapies except for residual toxicities which do not pose an ongoing medical risk.
  • If of childbearing potential, agree to use an effective method of contraception prior to study entry, for the duration of the study, and for 30 days after the last dose of MBP-426 with FA/5-FU. A negative pregnancy test must be documented at baseline. Patients may not breastfeed while in this study.
  • Have the ability to maintain a central IV access.
  • Able to comply with the protocol treatments and procedures.
  • Provide written informed consent indicating that they are aware of the investigational nature of this study and in keeping with the institution's policies.
  • Phase II:
  • Inoperable, histologically, or cytologically confirmed, locally advanced or metastatic gastric, GE junction, or esophageal adenocarcinoma that has recurred or progressed following 1 prior chemotherapy.
  • Measurable disease as defined by RECIST. If recurrence is documented following radiation therapy, the recurrence must have occurred outside the radiation field. Lesions which are located within a previously irradiated field are not considered measurable.
  • ECOG performance status: 0 or 1.
  • Identical to criteria numbers 3-10 for Phase Ib portion of the study.

Who cannot join

  • Major surgery within 14 days prior to study enrollment.
  • Radiotherapy, hormonal therapy, immunotherapy, or investigational agents within 30 days of enrollment (6 weeks for mitomycin C). A washout is required for chemotherapy, antibodies and small molecules, equivalent to at least 5 half-lives or 30 days, whichever is shorter, prior to study entry. Concurrent use of bisphosphonates is permitted.
  • Have had a past or have a current 2nd primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin, or other malignancy treated at least 3 years previously with surgery and/or radiotherapy and no evidence of recurrence since that time).
  • Known or clinical evidence of CNS metastases.
  • Receiving high-dose steroids more than a dexamethasone-equivalent dose of 4 mg/day.
  • Current active infections requiring anti-infectious treatment.
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  • Significant intercurrent illnesses that would have compromise the safety of the patient or compromise the ability of the patient to complete the study.
  • Documented or known hematologic malignancy and/or bleeding disorder.
  • Peripheral neuropathy ≥Gr 2 (NCI-CTCAE, Ver. 3.0).
  • Any requirement(s) for therapeutic anticoagulation that increases INR or aPTT above the normal range (low dose DVT or line prophylaxis is allowed).
  • Have NYHA Class 3 or 4 heart disease, active ischemia, or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy.
  • History of allergy to any of the treatment components (oxaliplatin, 5-FU, FA, liposome, ferritin).

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States3 sites

  • Mary Crowley Medical Research Center

    Dallas, Texas, 76201

  • MD Anderson

    Houston, Texas, 77030

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

Georgia2 sites

  • A.Gvamichava National Center of Cancer

    Tbilisi, 0177

  • Medulla Chemotherapy and Immunotherapy Clinic

    Tbilisi, 0186

Other trials in Georgia

About this study

Official title: A Phase Ib/II Study of MBP-426 in Patients With Second Line Gastric, Gastro Esophageal, or Esophageal Adenocarcinoma

The ongoing study is a Phase II, open-label study to evaluate the efficacy of MBP-426 at a dose of 170 mg/m2 in combination therapy in patients with second line metastatic gastric, gastro-esophageal junction or esophageal adenocarcinoma.

Read the detailed description

This study will start with a Phase Ib portion, at a dose of 226 mg/m2, a dose in which good tolerability was demonstrated in the Phase I trial. A cohort may be enrolled at 301 mg/m2, if 226 mg/m2 is well tolerated. The dose determined from the Phase Ib portion of the study will then be evaluated in the Phase II portion.

This design will permit evaluation of a true positive or negative response while limiting over exposure of patients to the study drug. If this regimen does offer a positive response, its reduced toxicity and potentially greater efficacy may yield better outcomes for patients requiring second-line therapy for UGI cancer.

Following completion of the Phase Ib part of the present trial, the dose recommended for use in the Phase II part is 170 mg/m2 MBP-426.

Being tested
MBP-426/Leucovorin/5-FU
Medical subject headings
Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBP-426/Leucovorin/5-FUDrug

    Also called Liposomal Oxaliplatin/Folinic Acid/5-Fluorouracil

    MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered at a dose of 400 mg/m2 after the MBP-426 infusion and in the absence of allergy/infusion reaction. 5-FU is administered concurrently with the leucovorin infusion and after the MBP-426 administration as a 46-hour continuous infusion of 2400 mg/m2.

Study groups in NCT00964080
Study groupRoleWhat they receive
Study of MBP-426/leucovorin/5-FUExperimentalStudy of MBP-426/leucovorin/5-FU. MBP-426 will be administered at a dose of 170 mg/m2 every three weeks. Leucovorin will be administered ata dose of 400 mg/m2 after the MBP-426 infusion and in the absence of allergy/infusion reaction. 5-FU is administered concurrently with the leucovorin infusion and after the MBP-426 administration as a 46-hour continuous infusion of 2400 mg/m2.
Receives: Drug: MBP-426/Leucovorin/5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the dose of MBP-426 for use in the Phase II portion of this study of MBP-426 administered every 21 days in combination with leucovorin (folinic acid or FA) and fluorouracil (5-FU)

    Measured: 4 months

Secondary outcomes (4)

  1. To characterize the safety profile of the combination therapy

    Measured: 4 months

  2. To determine the plasma and urine pharmacokinetics of MBP-426 when given in combination with leucovorin and 5-FU

    Measured: 4 months

  3. To undertake a preliminary exploration of anti-tumor activity of the combination therapy

    Measured: 4 months

  4. To characterize the safety profile of the combination therapy

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionOct 2012
  4. Study completionApr 2015 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00964080
Sponsor's protocol ID
MBP-426 201
Status last verified
Apr 2012
First submitted
17 Aug 2009
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MBP-426/Leucovorin/5-FU in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Mebiopharm Co., Ltd at 5 sites in 2 countries.

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 20 inclusion and 12 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: status not confirmed, 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 5 sites in United States, Georgia. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

To determine the dose of MBP-426 for use in the Phase II portion of this study of MBP-426 administered every 21 days in combination with leucovorin (folinic acid or FA) and fluorouracil (5-FU) (time frame: 4 months). 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 NCT00964080, 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.

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