Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1b Trial to Evaluate the Safety and Pharmacokinetics of Volociximab (M200) in Combination With Carboplatin and Paclitaxel in Subjects With Previously Untreated Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
Verified date | April 2012 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to examine the safety of volociximab in combination with a standard treatment of carboplatin and paclitaxel in subjects previously untreated with chemotherapy for advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC).
Status | Completed |
Enrollment | 33 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria 1. Males and females at least 18 years of age. 2. Stage IIIB or IV or recurrent NSCLC. 3. Measurable and/or evaluable disease according to RECIST. 4. No prior chemotherapy, biological therapy or immunotherapy for Stage IIIB/IV disease. Adjuvant therapy for early stage disease must have been completed > or = 6 months prior to Cycle 1, Day 1 of this study. 5. Eastern Cooperative Oncology Group (ECOG) performance status < or =1. 6. A negative pregnancy test (serum or urine) in women of childbearing potential at screening. Exclusion Criteria 1. Known allergy or sensitivity to murine proteins, chimeric antibodies or other components of the product, Cremophor EL (polyoxyethylated castor oil), cisplatin, or other platinum-containing compounds. 2. Absolute neutrophil count (ANC) <1500/mm3, hemoglobin level <9 g/dL, or a platelet count <100,000/mm3. 3. Aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase values of .2.5 of the upper limits of normal values (ULN) (>5 ULN for subjects with liver metastases) or alkaline phosphatase values >2.5 ULN (unless documented bone metastases are responsible for the increase of alkaline phosphatase); total bilirubin >1.5 mg/dL, or serum creatinine >1.8 mg/dL. 4. Radiation therapy within 1 month before Cycle 1, Day 1. 5. Documented symptomatic central nervous system (CNS) tumor or CNS metastases. 6. History of thromboembolic events, including cardiovascular or cerebrovascular events (ie, acute myocardial infarction [AMI], stroke) within 1 year prior to Cycle 1, Day 1. 7. History of known bleeding disorders and coagulation defects. 8. History of significant hemoptysis (ie, > or =1/2 teaspoon red blood per event) or gastrointestinal bleeding within 1 year prior to Cycle 1, Day 1. 9. Major surgery (eg, exploratory laparotomy) within 4 weeks prior to Cycle 1, Day 1 of the study. 10. Clinically significant or unstable medical conditions including, but not limited to, uncontrolled diabetes mellitus requiring insulin, uncontrolled hypertension, or uncontrolled or symptomatic orthostatic hypotension. 11. Oxygen-dependent chronic obstructive pulmonary disease. 12. Known active infections requiring intravenous (IV) antibiotics, antivirals, or antifungals, including but not limited to chronic human immunodeficiency virus, hepatitis B, or hepatitis C infection. 13. Prior bone marrow or stem cell transplant. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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AbbVie |
Besse B, Tsao LC, Chao DT, Fang Y, Soria JC, Almokadem S, Belani CP. Phase Ib safety and pharmacokinetic study of volociximab, an anti-a5ß1 integrin antibody, in combination with carboplatin and paclitaxel in advanced non-small-cell lung cancer. Ann Oncol — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin and paclitaxel | Dose escalation phase of the trial | ||
Secondary | Pharmacokinetics of volociximab | Approximately 2.5 years | ||
Secondary | Efficacy of volociximab in combination with carboplatin/paclitaxel | Approximately 2.5 years |
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