Clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC).
- Registration Number
- CTRI/2009/091/000822
- Lead Sponsor
- ereus Pharmaceuticals, Inc.10480 Wateridge CircleSan Diego, CA 92121USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 154
1. Male and females ≥ 18 years of age
2. ECOG performance status ≤ 1
3. 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
4. All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2
5. Signed informed consent
1. Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
2. Significant cardiac history
3. Prior treatment with tumor vascular disruptive agents
4. Seizure disorder
5. Brain metastases
6. Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
7. Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C
8. Patients with a prior hypersensitivity reaction to product components
9. Pregnant or breast-feeding women.
10. 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
11. Unwilling or unable to comply with procedures required in this protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method