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Hormone Refractory Prostate CancerPhase 2NCT00571675

A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

A Phase 2 study testing AT-101, prednisone and docetaxel in people with Hormone Refractory Prostate Cancer, run by Ascenta Therapeutics at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
AT-101, prednisone and docetaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
35 sitesin 2 countries
Study dates
Oct 2007to Sep 2010
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males age ≥ 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (e.g. any T, any N, M1a-c) based on bone scan, CT scan, or MRI scan.
  • Progression of disease despite androgen deprivation (androgen ablation or surgical castration) and anti-androgen withdrawal as documented by one or more of the following.
  • Progression of measurable disease per RECIST
  • Bone scan progression, defined as the appearance of ≥ 2 new lesions on bone scan, attributable to prostate cancer
  • Rising PSA, as defined by increasing levels on at least two consecutive assessments, following a prior assessment taken as a reference value, where all of the following are met:
  • The assessments are at least one week apart, with the first assessment at least one week later than the reference value
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  • Progressive increase in the two assessments after the reference value, without an intervening decrease between assessments.
  • The last value prior to study entry is ≥ 2 ng/mL
  • Serum testosterone level ≤ 50 ng/dL post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a LHRH agonist or antagonist.
  • At least 2 weeks since ketoconazole or systemic steroids (any dose); 2 weeks since prior flutamide, megestrol, or aminoglutethimide; and at least 2 weeks since prior bicalutamide or nilutamide
  • Radiation therapy and/or therapy with samarium must have been completed 4 weeks prior to first dose of therapy. Strontium therapy must have been completed at least 12 weeks prior to the first dose of therapy. The patient must have recovered from all treatment-related toxicities.
  • ECOG performance status ≤ 2
  • Able to swallow and retain oral medication

Who cannot join

  • Received prior chemotherapy (including estramustine phosphate [Estracyt]) for HRPC. Adjuvant chemotherapy (including docetaxel) is allowed provided that progression of disease occurred ≥ 6 months after the completion of adjuvant therapy.
  • Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH directed therapies are acceptable to maintain castrate levels of testosterone).
  • Treatment with monoclonal antibody (e.g., VEGF targeting antibody) or prostate cancer vaccine within 45 days prior to the first dose of study treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
  • Known history of or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
  • Active secondary malignancy or history of other malignancy within the last 5 years
  • Prior history of radiation therapy to ≥ 30% of the bone marrow
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  • Peripheral neuropathy of ≥ Grade 2
  • Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
  • Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
  • Known active symptomatic fungal, bacterial and/or viral infection including active HIV. Note: screening for viruses is not required.
  • Psychiatric illness/social situations that would limit compliance with the study requirements.

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States24 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Amarillo, Texas

  • Study site

    Arlington, Texas

  • Study site

    Austin, Texas

  • Study site

    Burnsville, Minnesota

  • Study site

    Colorado Springs, Colorado

  • Study site

    Dallas, Texas

  • Study site

    Denton, Texas

  • Study site

    Eugene, Oregon

  • Study site

    Fairfax, Virginia

  • Study site

    Fishers, Indiana

  • Study site

    Kennewick, Washington

  • Study site

    Kettering, Ohio

  • Study site

    Las Cruces, New Mexico

  • Study site

    Las Vegas, Nevada

  • Study site

    Midland, Texas

  • Study site

    New Port Richey, Florida

  • Study site

    Norfolk, Virginia

  • Study site

    Ocoee, Florida

  • Study site

    Paris, Texas

  • Study site

    Raleigh, North Carolina

  • Study site

    Spartanburg, South Carolina

  • Study site

    Vancouver, Washington

  • Study site

    Webster, Texas

Other trials in United States

Russia11 sites

  • Study site

    Barnaul

  • Study site

    Engel's

  • Study site

    Kazan'

  • Study site

    Kursk

  • Study site

    Kuzmolovsky

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Sochi

  • Study site

    Stavropol

  • Study site

    Voronezh

  • Study site

    Yekaterinburg

Other trials in Russia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.

Read the detailed description

Further Study Details provided by Ascenta.

Being tested
AT-101, prednisone and docetaxel, placebo, prednisone and docetaxel
Keywords
Prostate Cancer, Hormone Refractory Prostate Cancer, HRPC, Docetaxel, Taxotere, Prednisone, Metastatic (Stage IV) Disease, Chemotherapy-naïve metastatic Hormone Refractory Prostate Cancer (HRPC)
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis, Disease

What participants receive

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

  • AT-101, prednisone and docetaxelDrug

    docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3

  • placebo, prednisone and docetaxelDrug

    docetaxel (75mg/m2 intravenously over 1 hour every 21 days [one cycle]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3

Study groups in NCT00571675
Study groupRoleWhat they receive
1ExperimentalAT-101, prednisone and docetaxel
Receives: Drug: AT-101, prednisone and docetaxel
2Placebo comparatorPlacebo, prednisone and docetaxel
Receives: Drug: placebo, prednisone and docetaxel

What is being measured

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

  1. To evaluate and compare the two treatment arms with respect to overall survival (OS)

    Measured: 33 months

Secondary outcomes (3)

  1. To evaluate and compare progression-free survival (PFS) in men with chemotherapy-naïve metastatic HRPC treated with AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo.

    Measured: 33 months

  2. To determine the toxicities associated with oral AT-101 administered in combination with docetaxel and prednisone.

    Measured: 28 months

  3. To evaluate PSA and objective tumor response rate.

    Measured: 28 months

Timeline

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

  1. First posted12 Dec 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionSep 2010
  4. Study completionSep 2010

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00571675
Sponsor's protocol ID
AT-101-CS-205
Status last verified
Nov 2010
First submitted
11 Dec 2007
Last updated
9 Nov 2010
Results posted
No
Data monitoring committee
No

Publications

  • O'Neill AJ, Prencipe M, Dowling C, Fan Y, Mulrane L, Gallagher WM, O'Connor D, O'Connor R, Devery A, Corcoran C, Rani S, O'Driscoll L, Fitzpatrick JM, Watson RW. Characterisation and manipulation of docetaxel resistant prostate cancer cell lines. Mol Cancer. 2011 Oct 7;10:126. doi: 10.1186/1476-4598-10-126.

    PubMed 21982118

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AT-101, prednisone and docetaxel in people with Hormone Refractory Prostate Cancer, run by Ascenta Therapeutics at 35 sites in 2 countries.

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 13 inclusion and 11 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: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Russia. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate and compare the two treatment arms with respect to overall survival (OS) (time frame: 33 months). 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 NCT00571675, which also lists 1 linked publication.

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 9 Nov 2010.

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