Status:
COMPLETED
Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Nereus Pharmaceuticals, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 (angi...
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 (angi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00630110
Start Date
February 1 2008
End Date
June 1 2011
Last Update
August 16 2011
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
San Diego Pacific Oncology & Hematology Associates
Encinitas, California, United States, 92024
3
University San Diego Moores Cancer Center
San Diego, California, United States, 92093
4
Kaiser Permanente
San Diego, California, United States, 92108