Cancer
Conditions
Keywords
Non Small Cell Lung
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).
Interventions
DRUGdocetaxel
docetaxel (75 mg/m2)
DRUGNPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Sponsors
Nereus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 | Continuous |
Secondary
| Measure | Time frame |
|---|---|
| Compare response rate, duration of response, 6-month survival, progression free survival and safety. | Continuous |
| Pharmacokinetics | Continuous |
Countries
Argentina, Australia, Brazil, Chile, India, United States
Outcome results
None listed