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

Overview

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 Title of Study: “Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

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

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

Arms, Groups and Cohorts

  • Active Comparator: docetaxel
    • docetaxel (75 mg/m2)
  • Experimental: NPI-2358 + docetaxel
    • NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)

Clinical Trial Outcome Measures

Primary Measures

  • Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
    • Time Frame: Continuous

Secondary Measures

  • Compare response rate, duration of response, 6-month survival, progression free survival and safety.
    • Time Frame: Continuous
  • Pharmacokinetics
    • Time Frame: Continuous

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nereus Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Kristine C. Federico, RN BSN – Director Clinical Development, Nereus Pharmaceuticals, Inc.
  • Overall Official(s)
    • Matthew A Spear, MD, Study Director, Chief Medical Officer, Nereus Pharmaceuticals, Inc

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