Status:
COMPLETED
A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel in First-line, Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
AbbVie
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This Phase 1b, multicenter, open-label, dose-escalation study will evaluate the safety and pharmacokinetics (PK) of volociximab in combination with carboplatin and paclitaxel (C/P) as first-line treat...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females at least 18 years of age.
- Stage IIIB or IV or recurrent NSCLC.
- Measurable and/or evaluable disease according to RECIST.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status \< or =1.
- A negative pregnancy test (serum or urine) in women of childbearing potential at screening.
- Exclusion Criteria
- 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.
- Absolute neutrophil count (ANC) \<1500/mm3, hemoglobin level \<9 g/dL, or a platelet count \<100,000/mm3.
- 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.
- Radiation therapy within 1 month before Cycle 1, Day 1.
- Documented symptomatic central nervous system (CNS) tumor or CNS metastases.
- History of thromboembolic events, including cardiovascular or cerebrovascular events (ie, acute myocardial infarction \[AMI\], stroke) within 1 year prior to Cycle 1, Day 1.
- History of known bleeding disorders and coagulation defects.
- 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.
- Major surgery (eg, exploratory laparotomy) within 4 weeks prior to Cycle 1, Day 1 of the study.
- Clinically significant or unstable medical conditions including, but not limited to, uncontrolled diabetes mellitus requiring insulin, uncontrolled hypertension, or uncontrolled or symptomatic orthostatic hypotension.
- Oxygen-dependent chronic obstructive pulmonary disease.
- 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.
- Prior bone marrow or stem cell transplant.
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00654758
Start Date
December 1 2007
End Date
May 1 2010
Last Update
November 21 2017
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