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A Randomized, Phase II Study of Two Dose Levels of ATN-224 in Patients With Biochemically Relapsed, Early Stage Prostate Cancer Not on Hormone Therapy

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Randomized, Phase II Study of Two Dose Levels of ATN-224 in Patients With Biochemically Relapsed, Early Stage Prostate Cancer Not on Hormone Therapy

ATN-224 is an orally active, small molecule that has been shown in cellular and animal
models to be anti-angiogenic and to have activity against prostate cancer cell lines.
ATN-224 has the potential to affect the progression of prostate cancer by mechanisms that
include both antiangiogenic and antitumor pathways. ATN-224 may change the time to overt
metastatic disease in patients with rising PSA as the only manifestation of disease after
treatment with curative intent and delay the need for hormonal therapies.

Inclusion Criteria

Inclusion Criteria

- Patients with histologically confirmed, localized prostate cancer who have a
prostate-specific antigen (PSA) doubling time (DT) as calculated according to the
Memorial Sloan-Kettering Cancer Center nomogram

- Doubling time < 12 months after local therapy in patients who have not had any
previous hormone therapy, or

- Doubling time < 12 months starting at least 6 months after their last dose of
hormone therapy

- Patients must have a serum testosterone >150 ng/dL at the time of study entry.
Patients may have received previous castrating hormonal therapy or anti-androgens,
provided that the testosterone level is >150 ng/dL at the time of study entry. Prior
chemotherapy is also allowed as long as the requirements for adequate organ and
marrow function are met.

- No detectable disease as assessed by physical examination and bone and CT (abdomen
and pelvis) scans within 4 weeks prior to the first dose of ATN-224

- A minimum of three PSA values, each at least 4 weeks apart, to calculate PSA-DT. The
last PSA level prior to enrollment must be at least 2.0 ng/mL and be rising over the
prior value.

- Age ≥18 years

- Life expectancy of greater than 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥50%; see
Appendix A)

- Patients must have adequate organ and marrow function as defined below:

- absolute neutrophil count ≥1,500/uL

- platelets ≥100,000/uL

- hemoglobin ≥9 g/dL

- total bilirubin ≤2 X institutional upper limit of normal (ULN)


- creatinine clearance (measured or calculated) ≥30 mL/min

- serum testosterone >150 ng/mL or return to pre-treatment values for patients who
received hormone therapy

Patients are allowed to receive erythropoietin or blood transfusions before receiving
their first dose of ATN-224 to bring the hemoglobin level to >9 g/dL to meet eligibility

- At least 28 days from receiving any investigational agent

- The effects of ATN-224 on sperm at the recommended therapeutic dose are unknown. For
this reason men with partners of child-bearing potential must agree to use adequate
contraception (hormonal and/or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation through the follow up visit
28 days after the last dose of ATN-224

- Willingness to forgo taking copper- or zinc-containing vitamins or supplements

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

- Patients who have had radiotherapy within 3 months prior to the first dose of ATN 224

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ATN-224 or omeprazole or other long acting antacids

- History of malabsorption syndromes or other gastrointestinal disorders that may
affect ATN-224 absorption, including bowel obstruction, celiac disease, sprue, cystic

- Ineligible to receive either omeprazole (Prilosec®), lansoprazole (Prevacid®),
pantoprazole (Protonix®), or ranitidine (Zantac®)

- Inability to swallow study medication capsules

- Other serious medical or psychiatric illness preventing informed consent or with the
potential to interfere with assessment of safety or efficacy of ATN-224 treatment

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Patients known to be positive for HIV or infectious hepatitis type A, B or C

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer or any other cancer from which the patient
has been disease-free for 5 years

- Patients receiving steroid therapy for concurrent illness unless they have been on a
stable dose for 3 months.

- Patients receiving hormonal therapy including gonadotropin-releasing hormone
agonist/antagonist, antiandrogens, diethylstilbestrol, any other estrogen-like
agents, any hormonally active over-the-counter compounds such as PC-SPES or

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Gilad Gordon, MD

Investigator Role:

Study Director


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

September 2008

Related Keywords:

  • Prostate Cancer
  • prostate
  • PSA
  • antiangiogenic
  • copper
  • ATN-224
  • Prostatic Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
University of California San Francisco San Francisco, California  941104206
University of Texas MD Anderson Cancer Center Houston, Texas  77030
Oregon Health and Science University Portland, Oregon  97201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University Baltimore, Maryland  21231