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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Tumors, Neoplasms, Cancer

Thank you

Trial Information

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

Inclusion Criteria:

1. Patients with advanced and/or metastatic, histologically documented solid tumors.

2. 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).

3. Patients must have measurable or evaluable advanced and/or metastatic disease by

4. 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.

5. ECOG Performance status of 0 or 1.

6. Must be at least 18 years of age.

7. Expected survival of at least 3 months.

8. 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.

9. Must be able and willing to give written informed consent.

10. 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 <= 1.5x 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

11. Patients should have body Temperature <= 38.0 degrees C.

12. Echocardiogram demonstrated left ventricular ejection fraction >= 40%.

Exclusion Criteria:

1. Presence or history of brain metastases.

2. Presence of known or suspected ongoing ischemia of non-tumor tissues including

- ischemic peripheral vascular disease, myocardial infarction within the past 6

- 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

3. 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.

4. Patients with indwelling catheters (other than Portacath, Hickman or PICC lines)

5. Known cardiac valvular disease (e.g. bicuspid aortic valve) or arterial aneurysm(s)
that may allow a nidus of infection.

6. Known cardiac arrhythmias requiring medication.

7. 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.

8. Patients with baseline respiratory insufficiency severe enough to require
supplemental oxygen.

9. Patients with any pleural effusion or abdominal/peritoneal ascites.

10. Patients with

- radiotherapy, treatment with cytotoxic agents, or treatment with biologic agents
within 4 weeks prior to treatment with APS001F (6 weeks for mitomycin or

- At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.

- Must have 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). Patients that have received prior
treatment with 5-FU are eligible.

11. Presence of GI bleeding.

12. Currently using warfarin.

13. Active infection of any kind.

14. Currently using antibiotics and/or anti fungal agent (however, topical antibiotics
are permitted).

15. Presence of any condition or concurrent requirement for treatment with agents known
to result in immune deficiency.

16. Patients with documented immunodeficiency such as HIV infection.

17. Presence of autoimmune disease that requires corticosteroids and/or immunosuppressive

18. Patients with evidence of chronic active Hepatitis B (positive for HbsAg) and
Hepatitis C.

19. Hypersensitivity (history of allergic reactions) to

- 5-FC

- 5-FU

20. Patient's medical history does not contraindicate treatment with at least one of the
following antibiotics: ampicillin, clindamycin and erythromycin/clarithromycin.

21. Unwilling or unable to follow protocol requirements.

22. 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Tumors
  • Neoplasms
  • Cancer
  • Neoplasms



Mary Crowley Cancer Research Centers Dallas, Texas  75201