Prostate CancerPhase 1/2NCT00286793
Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC
A Phase 1/2 study testing AT-101 in people with Prostate Cancer, run by Ascenta Therapeutics at 13 sites in United States.
Trial summary
This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen, Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- AT-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2006to Nov 2009
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
- Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
- ECOG performance status 0 or 1
- Adequate hematologic function
- Adequate liver and renal function
- Able to swallow and retain oral medication.
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- Patients enrolled into Cohort B must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising PSA, progression of disease per RECIST, or >2 new lesions on bone scan.
- Patients enrolled into Cohort B must have received at least two cycles of docetaxel. Minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
- At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.
Who cannot join
- Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
- Known history of or clinical evidence of central nervous system (CNS) metastases.
- Active secondary malignancy or history of other malignancy within the last 5 years.
- Prior history of radiation therapy to > 25% of the bone marrow
- Peripheral neuropathy of > Grade 2
- Uncontrolled concurrent illness
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- Failure to recover fully, as judged by the investigator, from prior surgical procedures.
- Concurrent anti-cancer therapy other than docetaxel and prednisone.
- Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Albuquerque, New Mexico
Study site
Chicago, Illinois
Study site
Fort Meyers, Florida
Study site
Fridley, Minnesota
Study site
Germantown, Tennessee
Study site
Hilton Head Island, South Carolina
Study site
Hot Springs, Arkansas
Study site
Memphis, Tennessee
Study site
Nashville, Tennessee
Study site
Portland, Oregon
Study site
Richardson, Texas
Study site
Syracuse, New York
Study site
Wilmington, North Carolina
About this study
Official title: An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer (HRPC)
This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,
- Conditions
- Prostate Cancer
- Being tested
- AT-101
- Keywords
- at-101, at101, cancer, hormone refractory, prostate, docetaxel, prednisone
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-101Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| SIngle Arm Study of AT-101 in combination with Docetaxel | Experimental | Not described Receives: Drug: AT-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of AT-101 in combination with docetaxel and prednisone
Measured: 12 months
Secondary outcomes (1)
Preliminary efficacy of AT-101 in combination with docetaxel and prednisone
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascenta Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lance Leopold, MD, Study director, Ascenta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286793
- Sponsor's protocol ID
- AT-101-CS-202
- Status last verified
- Jun 2011
- First submitted
- 3 Feb 2006
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer (HRPC)
- ClinicalTrials.gov ID
- NCT00286793
- Acronym / sponsor ID
- AT-101-CS-202
- Conditions
- Prostate Cancer
- Keywords
- at-101, at101, cancer, hormone refractory, prostate, docetaxel, prednisone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ascenta TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIngle Arm Study of AT-101 in combination with Docetaxel | Experimental | Drug: AT-101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
- Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
- ECOG performance status 0 or 1
- Adequate hematologic function
- Adequate liver and renal function
Key exclusion criteria (9 listed)
- Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
- Known history of or clinical evidence of central nervous system (CNS) metastases.
- Active secondary malignancy or history of other malignancy within the last 5 years.
- Prior history of radiation therapy to > 25% of the bone marrow
- Peripheral neuropathy of > Grade 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-101Oral | Drug | SIngle Arm Study of AT-101 in combination with Docetaxel |
Primary outcome
Safety of AT-101 in combination with docetaxel and prednisone
Time frame: 12 months
1 secondary outcome
Preliminary efficacy of AT-101 in combination with docetaxel and prednisone
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lance Leopold, MD study director
Ascenta Therapeutics, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AT-101 in people with Prostate Cancer, run by Ascenta Therapeutics at 13 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 9 inclusion and 9 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 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of AT-101 in combination with docetaxel and prednisone (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2011.