Status:
UNKNOWN
Study of ATN-224 in Patients With Prostate Cancer
Lead Sponsor:
Attenuon
Collaborating Sponsors:
Prostate Cancer Clinical Trials Consortium
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, phase II study of the safety and efficacy of two dose levels of oral ATN-224 in patients with prostate cancer with a rising serum PSA in the absence of detectable di...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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 (http://www.mskcc.org/mskcc/html/10088.cfm)
- 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)
- AST(SGOT) and ALT(SGPT) ≤2 X 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 criteria.
- 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 fibrosis
- 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 finasteride
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00405574
Start Date
November 1 2006
End Date
September 1 2008
Last Update
January 30 2008
Active Locations (6)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 21205
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
4
Oregon Health and Science University
Portland, Oregon, United States, 97239