| February 3, 2006 |
| August 24, 2009 |
| February 2006 |
| March 2009 (final data collection date for primary outcome measure) |
| Safety of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] |
| Safety of AT-101 in combination with docetaxel and prednisone |
| Complete list of historical versions of study NCT00286793 on ClinicalTrials.gov Archive Site |
| Preliminary efficacy of AT-101 in combination with docetaxel and prednisone [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
| Preliminary efficacy of AT-101 in combination with docetaxel and prednisone |
| |
| Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer |
| 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, |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Prostate Cancer |
- Drug: AT-101
- Drug: Docetaxel
- Drug: Prednisone
|
| |
| |
| |
| Active, not recruiting |
| 75 |
| December 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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)
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| Male |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00286793 |
| Kimberli Brill, Associate Director, Clinical Development, Ascenta Therapeutics |
| AT-101-CS-202 |
| Ascenta Therapeutics |
|
| Study Director: |
Lance Leopold, MD |
Ascenta Therapeutics, Inc. |
|
|
| Ascenta Therapeutics |
| August 2009 |