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Study of ATN-224 in Patients With Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Attenuon.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00405574
First Posted: November 30, 2006
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Prostate Cancer Clinical Trials Consortium
Information provided by:
Attenuon
  Purpose
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 disease. Patients will be randomized (1:1) after confirmation of eligibility requirements. The primary endpoint is to determine the proportion of patients who do not have PSA progression for 24 weeks. PSA progression is defined as at least a 50% increase in PSA and >5 ng/mL from baseline or post-treatment nadir if lower than baseline, confirmed by another PSA at least 28 days later.

Condition Intervention Phase
Prostate Cancer Drug: ATN-224 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Attenuon:

Primary Outcome Measures:
  • Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Establish the safety of the two dose levels of ATN-224 [ Time Frame: 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 ]
  • Determine the change in PSA doubling time (PSA-DT) from baseline [ Time Frame: End of Study ]
  • Determine the maximal % decrease in PSA after treatment [ Time Frame: End of Study ]
  • Determine the time to PSA progression (as defined by this protocol) [ Time Frame: End of Study ]
  • Determine the 24-week rate of metastases [ Time Frame: 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 ]

Estimated Enrollment: 50
Study Start Date: November 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose
ATN-224 dose 300mg
Drug: ATN-224
ATN-224 high dose: 300mg ATN-224 low dose: 30mg
Experimental: Low Dose
ATN-224 dose: 30mg
Drug: ATN-224
ATN-224 high dose: 300mg ATN-224 low dose: 30mg

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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 (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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405574


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Attenuon
Prostate Cancer Clinical Trials Consortium
Investigators
Study Director: Gilad Gordon, MD
  More Information

Responsible Party: Jennifer Callahan, Senior Manager, Clinical Development, Attenuon, LLC
ClinicalTrials.gov Identifier: NCT00405574     History of Changes
Other Study ID Numbers: ATN-224-005
First Submitted: November 29, 2006
First Posted: November 30, 2006
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by Attenuon:
prostate
PSA
antiangiogenic
copper
ATN-224

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Tetrathiomolybdate
Molybdenum
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Trace Elements
Micronutrients