Study of ATN-224 in Patients With Prostate Cancer

NCT00405574 | Unknown Phase 2

• 1 other identifier: ATN-224-005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Prostate Cancer

Keywords

prostate; PSA; antiangiogenic; copper; ATN-224

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (7)

• Establish the safety of the two dose levels of ATN-224

  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

  End of Study

• Determine the change in PSA doubling time (PSA-DT) from baseline

  End of Study

• Determine the maximal % decrease in PSA after treatment

  End of Study

• Determine the time to PSA progression (as defined by this protocol)

  End of Study

Study Arms (2)

High Dose

EXPERIMENTAL

ATN-224 dose 300mg

Drug: ATN-224

Low Dose

EXPERIMENTAL

ATN-224 dose: 30mg

Drug: ATN-224

Interventions

ATN-224 DRUG

ATN-224 high dose: 300mg ATN-224 low dose: 30mg

High Dose; Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attenuon: lead
• Prostate Cancer Clinical Trials Consortium: collaborator

Study Sites (6)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tetrathiomolybdate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gilad Gordon, MD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 30, 2008

Record last verified: 2008-01

Locations

US (6)