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Prostate CancerPhase 2NCT00405574

Study of ATN-224 in Patients With Prostate Cancer

A Phase 2 study testing ATN-224 in people with Prostate Cancer, run by Attenuon at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
ATN-224
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesUnited States
Study dates
Nov 2006to Sep 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

    Baltimore, Maryland, 21205

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
ATN-224
Keywords
prostate, PSA, antiangiogenic, copper, ATN-224
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATN-224Drug

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

Study groups in NCT00405574
Study groupRoleWhat they receive
High DoseExperimentalATN-224 dose 300mg
Receives: Drug: ATN-224
Low DoseExperimentalATN-224 dose: 30mg
Receives: Drug: ATN-224

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 weeks

Secondary outcomes (7)

  1. Establish the safety of the two dose levels of ATN-224

    Measured: Ongoing

  2. Determine the proportion of patients with a 50% reduction from baseline of PSA confirmed by a second PSA value at least 28 days later

    Measured: End of Study

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

    Measured: End of Study

  4. Determine the maximal % decrease in PSA after treatment

    Measured: End of Study

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

    Measured: End of Study

  6. Determine the 24-week rate of metastases

    Measured: 24 weeks

  7. Determine the effect of ATN-224 treatment on levels of Cu,Zn-superoxide dismutase (SOD1) in red blood cells

    Measured: End of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJun 2008 (estimated)
  4. Study completionSep 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00405574
Sponsor's protocol ID
ATN-224-005
Status last verified
Jan 2008
First submitted
29 Nov 2006
Last updated
30 Jan 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATN-224 in people with Prostate Cancer, run by Attenuon at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00405574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.

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