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

NCT01562626 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-05-12

No results posted yet for this study

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, 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

Interventions

DRUG

APS001F

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

DRUG

Flucytosine (5-FC)

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

DRUG

10% maltose

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

Sponsors & Collaborators

  • Anaeropharma Science, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562626 on ClinicalTrials.gov