NCT01562626

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

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

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Anaeropharma Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Tumors
• Neoplasms
• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2012-03-26
• Last updated: 2021-05-12

Locations

2 sites across 1 country: United States