Clinical Trials
- Non-Small Cell Lung Cancer (NSCLC)
- Hormone-Refractory Prostate Cancer (HRPC)
- Gastrointestinal (Esophageal) Cancer
- Brain Cancer (Glioblastoma Multiforme)
Non-Small Cell Lung Cancer (NSCLC)
Trial Number—AT-101-CS-204
A randomized, double-blind phase II trial comparing the safety and efficacy of the combination of AT-101 and docetaxel with docetaxel alone in patients with relapsed/refractory non-small cell lung cancer.
Where is this study being conducted?
This study is being conducted at various sites within the United States, Russia, and the Ukraine.
Who is conducting the trial?
This trial is being sponsored by Ascenta Therapeutics, Inc.
Who can participate?
- Adults with Stage IIIb non-small cell lung cancer or Stage IV non-small cell lung cancer, confirmed by a pathologist.
- Patients must have progressed after 1 prior systemic chemotherapeutic regimen.
- Patients with unstable or progressive brain metastases are not eligible.
What is AT-101?
AT-101 activates a pathway inside cancer cells resulting in the death of those cells. It is given by mouth in the form of pills.
What is docetaxel?
Docetaxel is a form of chemotherapy that nonspecifically kills cells that are rapidly dividing in the body, including cancer cells. It is given once every 3 weeks through an intravenous (IV) infusion over the course of 1 hour.
What do I do if I am interested in participating in this clinical trial?
Contact your physician. Your physician will be able to advise you about participating.
Click here to print a printer-friendly page.Trial Identification Number
NCT00544960
For more information on this trial, please visit www.clinicaltrials.gov
Hormone-Refractory Prostate Cancer (HRPC)
Trial Number—AT-101-CS-202
An open-label, multicenter phase I/II trial assessing the safety and efficacy of AT-101, a new treatment for prostate cancer, in combination with docetaxel and prednisone in men with HRPC.
Where is this study being conducted?
This trial is currently being conducted at several study sites within the United States.
Who is conducting the trial?
This trial is being sponsored by Ascenta Therapeutics, Inc.
Who can participate?
- Men whose prostate-specific antigen (PSA) levels are rising despite treatment to drastically reduce testosterone levels.
- Men with confirmed metastatic disease and adequate blood, liver, and renal function.
- Patients who can swallow medication.
- Patients with brain metastases are not eligible.
- Patients are not permitted to take other anticancer medications or antiandrogen hormonal therapy during the trial.
What is AT-101?
AT-101 activates a pathway inside cancer cells resulting in the death of those cells. It is given by mouth in the form of pills.
What is docetaxel?
Docetaxel is a form of chemotherapy that nonspecifically kills cells that are rapidly dividing in the body, including cancer cells. It is given once every 3 weeks through an intravenous (IV) infusion over the course of 1 hour.
What is prednisone?
Prednisone is a steroid that decreases inflammation. It is given as a pill or liquid by mouth with food.
What do I do if I am interested in participating in this clinical trial?
Contact your physician. Your physician will be able to advise you about participating.
Trial Identification Number
NCT00286793
For more information on this trial, please visit www.clinicaltrials.gov
Hormone-Refractory Prostate Cancer (HRPC)
Trial Number—AT-101-CS-205
A randomized, double-blind, placebo-controlled phase II trial comparing the safety and efficacy of the combination of AT-101, docetaxel, and prednisone versus docetaxel and prednisone alone in men with metastatic hormone-refractory prostate cancer (HRPC) who have not received prior chemotherapy
Where is this study being conducted?
This trial is currently being conducted at several study sites within the United States and Russia.
Who is conducting the trial?
This trial is being sponsored by Ascenta Therapeutics, Inc.
Who can participate?
- Men with confirmed adenocarcinoma of the prostate that has spread and has progressed despite androgen deprivation
- Patients must have adequate blood, liver, and renal function.
- Patients must be able to swallow medication.
- Patients who have received prior chemotherapy for the treatment of prostate cancer are not eligible. Patients who received adjuvant chemotherapy and progressed ≥6 months after completion of chemotherapy are also eligible.
- Patients are not permitted to take other antiandrogen hormonal therapy during the trial and must not have received treatment with monoclonal antibodies or prostate cancer vaccine within 45 days of the first dose of study medication.
What is AT-101?
AT-101 activates a pathway inside cancer cells resulting in the death of those cells. It is given by mouth in the form of pills.
What is docetaxel?
Docetaxel is a form of chemotherapy that nonspecifically kills cells that are rapidly dividing in the body including the cancer cells. It is given once every 3 weeks through an intravenous (IV) infusion over the course of 1 hour.
What is prednisone?
Prednisone is a steroid that decreases inflammation. It is given as a pill or liquid by mouth with food.
What do I do if I am interested in participating in this clinical trial?
Print this page. Contact your physician. Your physician will be able to advise you about participating.
Trial Identification Number
NCT00571675
For more information on this trial, please visit www.clinicaltrials.gov
Gastrointestinal (Esophageal) Cancer
Trial Number—AT-101-CS-102
An open-label, single center, phase I/II trial to evaluate the safety and efficacy of the combination of chemoradiotherapy and AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer
Where is this study being conducted?
This study is currently being conducted at MD Anderson Cancer Center.
Who is conducting the trial?
This trial is being sponsored by Ascenta Therapeutics, Inc.
Who can participate?
- Adults with histologically confirmed primary adenocarcinoma or squamous cell carcinoma of the esophagus or adenocarcinoma of the gastroesophageal junction.
- Patients with distant metastases are not eligible.
What is AT-101?
AT-101 activates a pathway inside cancer cells resulting in the death of those cells. It is given by mouth in the form of pills.
What is chemoradiotherapy?
Chemoradiotherapy combines chemotherapy with radiotherapy.
What do I do if I am interested in participating in this clinical trial?
Contact your physician. Your physician will be able to advise you about participating.
Trial Identification Number
NCT00561197
For more information on this trial, please visit www.clinicaltrials.gov
Brain Cancer (Glioblastoma Multiforme)
An open-label phase I trial to study side effects and the best dose of AT-101 to give with temozolomide with or without radiation therapy
Where is this study being conducted?
This study is being conducted at multiple sites within the United States.
Who is conducting the trial?
This trial is being sponsored by Ascenta Therapeutics, Inc., and the National Cancer Institute.
Who can participate?
- Adults with histologically confirmed supratentorial Grade IV astrocytoma (gliobastoma multiforme)
- Patients must be on a stable corticosteroid regimen.
What is AT-101?
AT-101 activates a pathway inside cancer cells resulting in the death of those cells. It is given by mouth in the form of pills.
What is temozolomide?
Temozolomide is a chemotherapy agent.
What do I do if I am interested in participating in this clinical trial?
Contact your physician. Your physician will be able to advise you about participating.
Trial Identification Number
NCT00390403