- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00405574
Study of ATN-224 in Patients With Prostate Cancer
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
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California San Francisco
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
-
-
New York
-
New York, New York, United States, 10021
- Memorial Sloan Kettering Cancer Center
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Dose
ATN-224 dose 300mg
|
ATN-224 high dose: 300mg ATN-224 low dose: 30mg
|
Experimental: Low Dose
ATN-224 dose: 30mg
|
ATN-224 high dose: 300mg ATN-224 low dose: 30mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Establish the safety of the two dose levels of ATN-224
Time Frame: Ongoing
|
Ongoing
|
Determine the proportion of patients with a 50% reduction from baseline of PSA confirmed by a second PSA value at least 28 days later
Time Frame: End of Study
|
End of Study
|
Determine the change in PSA doubling time (PSA-DT) from baseline
Time Frame: End of Study
|
End of Study
|
Determine the maximal % decrease in PSA after treatment
Time Frame: End of Study
|
End of Study
|
Determine the time to PSA progression (as defined by this protocol)
Time Frame: End of Study
|
End of Study
|
Determine the 24-week rate of metastases
Time Frame: 24 weeks
|
24 weeks
|
Determine the effect of ATN-224 treatment on levels of Cu,Zn-superoxide dismutase (SOD1) in red blood cells
Time Frame: End of Study
|
End of Study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Gilad Gordon, MD
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Chelating Agents
- Sequestering Agents
- Tetrathiomolybdate
Other Study ID Numbers
- ATN-224-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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