Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Nereus Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cancer

Treatments: Drug: NPI-2358 + docetaxel; Drug: docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630110

NPI-2358-101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

docetaxel

Active Comparator group

Description:

docetaxel (75 mg/m2)

Treatment:

Drug: docetaxel

NPI-2358 + docetaxel

Experimental group

Description:

NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)

Treatment:

Drug: NPI-2358 + docetaxel