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

This study has been completed.
Sponsor:
Information provided by:
Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00630110
First received: February 26, 2008
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: docetaxel
Drug: NPI-2358 + docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Nereus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare response rate, duration of response, 6-month survival, progression free survival and safety. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: February 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: docetaxel
docetaxel (75 mg/m2)
Drug: docetaxel
docetaxel (75 mg/m2)
Other Name: docetaxel (Taxotere)
Experimental: NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Drug: NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Other Name: NPI-2358; docetaxel (Taxotere)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630110

  Show 36 Study Locations
Sponsors and Collaborators
Nereus Pharmaceuticals, Inc.
Investigators
Study Director: Matthew A Spear, MD Chief Medical Officer, Nereus Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Kristine C. Federico, RN BSN - Director Clinical Development, Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00630110     History of Changes
Other Study ID Numbers: NPI-2358-101
Study First Received: February 26, 2008
Last Updated: August 15, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration
India: Drugs Controller General of India
Chile: Instituto de Salud Pública de Chile

Keywords provided by Nereus Pharmaceuticals, Inc.:
Non Small Cell Lung

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014