Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT00630110
- Lead Sponsor
- Nereus Pharmaceuticals, Inc.
- Brief Summary
This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues.
- Detailed Description
This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. There are indications of advantages in combining vascular disrupting agents with standard agents in the treatment of advanced non-small cell lung cancer (NSCLC).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
- Male and females ≥ 18 years of age
- ECOG performance status ≤ 1
- Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2
- Signed informed consent
- Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
- Significant cardiac history
- Prior treatment with tumor vascular disruptive agents
- Seizure disorder
- Brain metastases
- Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
- Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C
- Patients with a prior hypersensitivity reaction to product components
- Pregnant or breast-feeding women.
- Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Unwilling or unable to comply with procedures required in this protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description docetaxel docetaxel docetaxel (75 mg/m2) NPI-2358 + docetaxel NPI-2358 + docetaxel NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
- Primary Outcome Measures
Name Time Method Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 Continuous
- Secondary Outcome Measures
Name Time Method Compare response rate, duration of response, 6-month survival, progression free survival and safety. Continuous Pharmacokinetics Continuous
Trial Locations
- Locations (36)
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
San Diego Pacific Oncology & Hematology Associates
🇺🇸Encinitas, California, United States
University San Diego Moores Cancer Center
🇺🇸San Diego, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Premiere Oncology
🇺🇸Santa Monica, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University Texas Health Science Center at San Antonio (CTRC)
🇺🇸San Antonio, Texas, United States
Policlinica Privada Instituto de Medicina Nuclear
🇦🇷Bahia Blanca, Argentina
Hospital Britanico
🇦🇷Capital Federal, Argentina
Scroll for more (26 remaining)Mayo Clinic🇺🇸Scottsdale, Arizona, United States