Status:
COMPLETED
A Trial of PDL192 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Abbott
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors.
Detailed Description
The primary study objective is to determine the maximum tolerated dose of PDL192 in subjects with advanced solid tumors.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- Male or female, 18 years of age or older.
- Subjects with documented advanced solid tumors.
- Subjects who have previously failed all standard therapies or subjects who have a tumor where no standard therapy exists.
- A negative serum pregnancy test (women of childbearing potential only) at screening. Male or female subjects of reproductive potential must be willing to use adequate contraception during the duration of the study and for a minimum of 3 months after the end of treatment.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
- Exclusion Criteria
- Subjects will be ineligible for this study if they meet any one of the following criteria:
- Symptomatic and progressive central nervous system (CNS) metastases or leptomeningeal metastases
- Diagnosis of glioblastoma
- Eastern Cooperative Oncology Group (ECOG) performance status \>= 2
- Abnormal hematologic values defined as:
- Hemoglobin level \< 9 g/dL
- Absolute neutrophil count (ANC) \< 1500/mm3
- Platelet count \< 100,000/mm3
- Abnormal kidney, liver, or pancreatic function defined as:
- Serum creatinine \> 1.5 x upper limit of normal value (ULN)
- Aspartate transaminase or alanine transaminase levels of \> = 2.5 x ULN
- Bilirubin \> ULN
- Amylase \> 1.5 x ULN
- Lipase \> 1.5 x ULN
- Known chronic viral hepatitis
- History of cirrhotic liver disease
- History of pancreatitis (patients with history of gall stone pancreatitis who are status post-cholecystectomy will be eligible)
- Acute cholecystitis within 6 months prior to the first dose of study drug
- Treatment with any investigational drug, antineoplastic agent, or antibodies within 21 days prior to the first dose of study drug (6 weeks for vaccines or nitrosureas)
- Proteinuria \>1 g/24 hours (only subjects with \> = 2+ with dipstick test will undergo 24 hour urine collection)
- Ongoing \>= Grade 2 toxicities resulting from prior therapies
- Received continuous systemic steroids at doses greater than 10 mg/day of prednisone or its equivalent within 30 days prior to the first dose of study drug (intermittent dexamethasone given for prophylaxis or treatment of emesis is permitted)
- Received any immunosuppressive agent (except steroids) within 21 days prior to the first dose of study drug
- Known hypersensitivity to any component of the PDL192 formulation
- Uncontrolled medical problems such as diabetes mellitus, pancreatitis, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, or symptomatic heart failure
- Female subjects who are pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00738764
Start Date
July 1 2008
End Date
October 1 2011
Last Update
January 6 2012
Active Locations (2)
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1
Site Reference ID/Investigator# 53365
Scottsdale, Arizona, United States, 85258
2
Site Reference ID/Investigator# 53364
Aurora, Colorado, United States, 80045