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TumorsPhase 1/2NCT01562626

Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors

A Phase 1/2 study testing APS001F, Flucytosine (5-FC) and 10% maltose in people with Tumors and Neoplasms, run by Anaeropharma Science, Inc. at 2 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The purpose of this study is to test the safety and efficacy of an investigational drug called APS001F when given with flucytosine (5-FC) for treatment of solid tumors. APS001F is a recombinant Bifidobacterium longum (a live bacteria normally found in the digestive tract) that has been modified to produce an enzyme… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors, Neoplasms, Cancer
What is being tested?
APS001F, Flucytosine (5-FC) and 10% maltose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesUnited States
Study dates
Sep 2012to May 2021
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

  • Patients with advanced and/or metastatic, histologically documented solid tumors.
  • Patients must have disease that is no longer considered responsive to available conventional modalities or treatments (failed any known standard curative or effective therapy for that disease).
  • Patients must have measurable or evaluable advanced and/or metastatic disease by RECIST 1.1.
  • Patients enrolled at Dose Level 6 or higher in the phase I portion of the trial must have at least one tumor mass suitable and easily accessible for excisional biopsy, or alternatively, accessible for CT or ultrasound guided core needle biopsy. The procedure must be able to be performed with minimum morbidity.
  • ECOG Performance status of 0 or 1.
  • Must be at least 18 years of age.
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  • Expected survival of at least 3 months.
  • Men and women of child-bearing potential (i.e., women who are premenopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), oral contraceptive or double barrier device), and women must have a negative serum or urine pregnancy test 1 week before beginning treatment on this trial. Nursing patients are also excluded.
  • Must be able and willing to give written informed consent.
  • Patients must have adequate major organ function and meet the following criteria:
  • white blood cell (WBC)count >= 3,000/mm3.
  • Absolute neutrophil count (ANC) >= 1500/uL.
  • Platelets >= 100,000/mm3.
  • Hemoglobin >= 9.0g/dL
  • Serum creatinine <= 1.5 mg/dL. (or estimated creatinine clearance >= 50 ml/min/1.73 m2)
  • Bilirubin <= 1.5 mg/dL; ALT, AST, and alkaline phosphatase <= 3.0x the upper limit of normal
  • Prothrombin Time (PT) and activated partial thromboplastin time (aPTT) <= 1.5x the upper limit of normal.
  • Oxygen saturation >= 90% by pulse oximetry
  • Patients should have body Temperature <= 38.0 degrees C.
  • Echocardiogram demonstrated left ventricular ejection fraction >= 40%.

Who cannot join

  • Presence or history of brain metastases.
  • Presence of known or suspected ongoing ischemia of non-tumor tissues including
  • ischemic peripheral vascular disease, myocardial infarction within the past 6 months,
  • congestive heart failure > class II NYHA,
  • unstable angina (anginal symptoms at rest) or new onset angina (i.e., began within the last 3 months).
  • cerebrovascular accident, including transient ischemic attacks within the past 6 months.
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  • An artificial implant that cannot be easily removed (e.g., heart valves, prosthetic hips or knees, or other devices), which could allow a nidus of infection.
  • Patients with indwelling catheters (other than Portacath, Hickman or PICC lines)
  • Known cardiac valvular disease (e.g. bicuspid aortic valve) or arterial aneurysm(s) that may allow a nidus of infection.
  • Known cardiac arrhythmias requiring medication.
  • Patients with any of the following cardiovascular conditions: patent foramen ovale, prior history of bacterial endocarditis, any existing thrombus (either arterial or venous) as well as known history of DVT, permanent pacemakers, AICDs, LVADs, or other intravascular cardiac device, known AV malformations.
  • Patients with baseline respiratory insufficiency severe enough to require supplemental oxygen.
  • Patients with pleural effusion or abdominal/peritoneal ascites, except the finding of physiological levels of fluid.
  • Patients who have not fully recovered from toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). The required minimum time elapsed from prior treatments are:
  • treatment with cytotoxic agents, or treatment with biologic agents within 4 weeks prior to treatment with APS001F (6 weeks for mitomycin C or nitrosoureas).
  • treatment with molecular targeted agents within 2 weeks prior to treatment with APS001F.
  • radiotherapy within 4 weeks prior to treatment with APS001F (intensive radiotherapy within 6 weeks or palliative radiotherapy within 2 weeks).
  • At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
  • Presence of GI bleeding.
  • Currently using warfarin.
  • Active infection of any kind.
  • Currently using antibiotics and/or anti fungal agent (however, topical antibiotics are permitted).
  • Presence of any condition or concurrent requirement for treatment with agents known to result in immune deficiency.
  • Patients with documented immunodeficiency such as HIV infection.
  • Presence of autoimmune disease that requires corticosteroids and/or immunosuppressive agents.
  • Patients with evidence of chronic active Hepatitis B (positive for HbsAg) and Hepatitis C (positive for viral RNA).
  • Hypersensitivity (history of allergic reactions) to
  • 5-FC
  • 5-FU
  • Patient's medical history does not contraindicate treatment with at least one of the following antibiotics: ampicillin, clindamycin and erythromycin/clarithromycin.
  • Unwilling or unable to follow protocol requirements.
  • Presence of any concurrent illness or condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • MD Anderson

    Houston, Texas, 77030

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: A Phase I/II Safety, Pharmacokinetic, and Pharmacodynamic Study of APS001F With Flucytosine and Maltose for the Treatment of Advanced and/or Metastatic Solid Tumors

The purpose of this study is to test the safety and efficacy of an investigational drug called APS001F when given with flucytosine (5-FC) for treatment of solid tumors. APS001F is a recombinant Bifidobacterium longum (a live bacteria normally found in the digestive tract) that has been modified to produce an enzyme, cytosine deaminase (CD). The patient will first receive an injection of APS001F followed by oral 5-FC. APS001F is expected to go to the site of the tumor(s) where the agent will produce CD enzyme. CD enzyme will convert the 5-FC into 5-fluorouracil (5-FU) which is a standard chemotherapy drug for several types of cancer. Additionally, some patients will also receive 10% maltose injection, a sugar that has been shown to enhance the growth and effectiveness of APS001F in animals. This is the first study where APS001F is being used in humans.

Conditions
Tumors, Neoplasms, Cancer
Being tested
APS001F, Flucytosine (5-FC), 10% maltose
Medical subject headings
Neoplasms

What participants receive

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

  • APS001FDrug

    APS001F infusion on Days 1,2,3 of each 28 day cycle.

  • Flucytosine (5-FC)Drug

    oral doses on Days 11-15 and 18-22, each 28 day cycle

  • 10% maltoseDrug

    10% maltose infusion will be administered on Days 1-5, 8-12, and 15-19, each 28 day cycle.

Study groups in NCT01562626
Study groupRoleWhat they receive
Dose escalationExperimentalNot described
Receives: Drug: APS001F; Drug: Flucytosine (5-FC); Drug: 10% maltose

What is being measured

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

  1. Number of participants with adverse events as a measure of safety and tolerability of APS001F treatment plus 5-FC and maltose

    Measured: Starting from date of first dose up to 30 days after last dose

Timeline

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

  1. First posted26 Mar 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (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
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01562626
Sponsor's protocol ID
APS001F-001
Status last verified
May 2021
First submitted
22 Mar 2012
Last updated
12 May 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing APS001F, Flucytosine (5-FC) and 10% maltose in people with Tumors and Neoplasms, run by Anaeropharma Science, Inc. 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 20 inclusion and 32 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: paused, as of the sponsor's last update on 12 May 2021. 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 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?

Number of participants with adverse events as a measure of safety and tolerability of APS001F treatment plus 5-FC and maltose (time frame: Starting from date of first dose up to 30 days after last dose). 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 NCT01562626.

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 12 May 2021.

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