Clinical Trials
- Non-Small Cell Lung Cancer (NSCLC)
- Hormone-Refractory Prostate Cancer (HRPC)
- Esophageal or Gastroesophageal Junction 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.
Primary Objective
- To estimate and compare the progression-free survival of AT-101 combined with docetaxel versus docetaxel alone
Secondary Objective
- To evaluate the safety of AT-101 and docetaxel and secondary efficacy measure
Key Inclusion Criteria
- Adults with histologically or cytologically confirmed Stage IIIb non-small cell lung cancer or Stage IV non-small cell lung cancer
- Progression of disease after 1 prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the 1 prior chemotherapeutic regimen, patients may have received erlotinib in any setting.
- All patients must have measurable disease.
- Patients may have received prior radiation therapy, but they must have recovered from all treatment-related toxicities.
- ECOG performance status 0 to 2
- Adequate hematologic, liver, and renal function
- Ability to swallow oral medication
Key Exclusion Criteria
- Patients with unstable or progressive brain metastases are not eligible.
- Prior chemotherapy regimen containing docetaxel
- Active secondary malignancy
- Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
- Failure to recover from toxicities related to prior therapy (eg, surgery, radiation, chemotherapy)
Location and Contact Information
For more information on this trial, please contact Mr. Wood or Dr. Leopold using the information provided below.
Brian Wood (610) 408-0301 bwood@ascenta.com
Lance Leopold, MD (610) 408-0301 lleopold@ascenta.com
This study is currently being conducted at study sites within the United States, Russia, and Ukraine.
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.
Primary Objective
- To evaluate the safety of AT-101 in combination with docetaxel and prednisone
Secondary Objective
- To evaluate preliminary efficacy of AT-101 in combination with docetaxel and prednisone
Key Inclusion Criteria
- Rising prostate-specific antigen (PSA) levels despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy
- Metastatic disease confirmed 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
- Ability to swallow and retain oral medication
- Patients enrolled into Cohort B (progressed on a docetaxel-containing regimen) must have documented progression using 1 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 2 cycles of docetaxel with minimum doses of prior docetaxel of 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
Key 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.
- History of radiation therapy to >/= 25% of the bone marrow.
- Peripheral neuropathy of >/= Grade 2
- Uncontrolled concurrent illness
- Failure to recover fully from prior surgical procedures, as judged by the investigator
- Concurrent anticancer therapy other than docetaxel and prednisone
- Patients must not be receiving concurrent antiandrogen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone).
Study Design
Phase I - Completed
Phase II - Now enrolling patients into Cohort B. Cohort A is closed.
Location and Contact Information
For more information on this trial, please contact Ms. Brill or Dr. Leopold using the information provided below.
Kimberli Brill, BSN (610) 408-0301 kbrill@ascenta.com
Lance Leopold, MD (610) 408-0301 lleopold@ascenta.com
This study is currently being conducted at several study sites within the United States.
Trial Identification Number
NCT00286793
For more information on this trial, please visit www.clinicaltrials.gov
Hormone-Refractory Prostate Cancer (HRPC)
Phase II
Trial Number—AT-101-CS-205
A randomized, double-blind, placebo-controlled, multicenter, phase II study comparing AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone in men with chemotherapy-na�ve metastatic HRPC
Primary Objective
- To evaluate and compare progression-free survival between the two treatment arm
Secondary Objective
- To determine the safety of oral AT-101 administered in combination with docetaxel and prednisone
- To evaluate the two treatment arms with respect to change in quality of life status and Present Pain Intensity (PPI) score
- To evaluate prostate specific antigen (PSA) and objective tumor response rate
Key Inclusion Criteria
- Males age >/= 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (eg, 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 1 week apart, with the first assessment at least 1 week later than the reference value.
- Progressive increase in the 2 assessments after the reference value, without an intervening decrease between assessments
- The last PSA value before study entry is >/=2 ng/mL.
- Serum testosterone level
- At least 4 weeks since prior flutamide, megestrol, ketoconazole, aminoglutethimide, radiation therapy, samarium, or systemic steroids (any dose); and at least 6 weeks since prior bicalutamide or nilutamide
- ECOG performance status
- Able to swallow and retain oral medication
Key Exclusion Criteria
- Received prior chemotherapy (including estramustine phosphate) for HRPC. Adjuvant chemotherapy (including docetaxel) is allowed if progression of disease occurred >/=6 months after the completion of adjuvant therapy.
- Patients must not be receiving concurrent antiandrogen hormonal therapy for HRPC (LHRH-directed therapies are acceptable to maintain castrate levels of testosterone).
- 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
- 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.
Location and Contact Information
For more information on this trial, please contact Ms. Brookes or Dr. Leopold using the information provided below.
Melissa Brookes (610) 408-0301 mbrookes@ascenta.com
Lance Leopold, MD (610) 408-0301 lleopold@ascenta.com
This study is currently being conducted at several study sites within the United States and Russia.
Trial Identification Number
NCT00571675
For more information on this trial, please visit www.clinicaltrials.gov
Esophageal or Gastroesophageal Junction 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
Primary Objective
- To evaluate the safety and tolerability of AT-101 in combination with chemoradiotherapy and to determine the dose for phase II
- In the phase II portion of the study, to determine the pathologic complete response rate and to correlate tumor biomarker expression with clinical response
Secondary Objective
- To assess the safety and toxicity of chemoradiotherapy and AT-101 in patients with esophageal or gastroesophageal junction cancer
Key Inclusion Criteria
- Male or female patients age >/=18 years
- Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction
- For phase I: phase I patients must have unresectable disease (Stage II to IVa). A patient can be unresectable for medical reasons or technical reasons but eligible for chemoradiation.
- For phase II: phase II patients must have resectable cancer defined as: T2, T3, N0; or T1-3, N+
- Patients must have archived tumor tissue to correlate tumor biomarker expression with clinical response. Availability of tumor specimens in paraffin blocks or at least 2 unstained slides must be confirmed before study entry. Results will not be used to determine patient eligibility for the study.
- ECOG Performance Status 0 or 1
- Adequate hematologic, liver, and renal function
- Ability to swallow and retain oral medication
Key Exclusion Criteria
- Patients with distant metastases, including M1b lymph node status. (M1b status allowed on phase I only for patients appropriate for chemoradiation.) Lymph nodes suspicious of M1b status by diagnostic imaging must be verified by fine-needle aspiration cytology. (phase II only)
- For phase II: patients with positive pleural, pericardial, or peritoneal cytology
- For phase II: patients with carcinoma of the cervical esophagus
- For phase II: patients with clinical evidence of metastasis to cervical or supraclavicular lymph nodes
- Prior chemotherapy or radiotherapy for esophageal or gastroesophageal junction cancer. Phase I patients with prior chemotherapy are permitted to enter.
- Prior radiotherapy that would overlap the anticipated study treatment fields or radiotherapy to >30% of the marrow cavity (no prior chest irradiation).
- 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.
- Pregnant or nursing females. Fertile patients (male and female) must use effective contraception.
Location and Contact Information
For more information on this trial, please contact Ms. Brookes or Dr. Leopold using the information provided below.
Melissa Brookes (610) 408-0301 mbrookes@ascenta.com
Lance Leopold, MD (610) 408-0301 lleopold@ascenta.com
This study is currently being conducted at MD Anderson Cancer Center.
Trial Identification Number
NCT00561197
For more information on this trial, please visit www.clinicaltrials.gov
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
Primary Objective
- To determine the maximum tolerated dose of AT-101 when administered with radiotherapy and concurrent temozolomide
- To determine the maximum tolerated dose of AT-101 when administered with adjuvant temozolomide after standard radiotherapy and concurrent temozolomide
Secondary Objective
- To assess the toxicity of these treatment regimens
- To assess and describe the pharmacokinetics of AT-101
- To preliminarily determine the therapeutic activities of these regimens
- To determine the relationship between these regimens and cellular and molecular features identified in tumor biopsy specimens
Key Inclusion Criteria
- Adults with histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
- Completed surgery within the past 6 weeks (group I)
- Received radiotherapy and concomitant temozolomide at least 4 weeks but no more than 7 weeks before the start of study treatment
- Patients must be on a stable corticosteroid regimen
- Patients must have the following characteristics
- Karnofsky score 60%-100%
- Adequate hematologic, liver, and renal function
- Ability to swallow oral medication
Location and Contact Information
This study is currently being conducted at multiple sites within the United States.
Trial Identification Number
NCT00390403