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

Information source: Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: docetaxel (Drug); NPI-2358 + docetaxel (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Nereus Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Matthew A Spear, MD, Study Director, Affiliation: Chief Medical Officer, Nereus Pharmaceuticals, Inc

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358

Secondary outcome:

Compare response rate, duration of response, 6-month survival, progression free survival and safety.

Pharmacokinetics

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Policlinica Privada Instituto de Medicina Nuclear, Bahia Blanca, Argentina

Hospital Britanico, Capital Federal, Argentina

Clinica Universitaria Privada Reina Fabiola, Cordoba 5000CRD, Argentina

Instituto Oncologico De Cordoba, Cordoba 5000 CRD, Argentina

Caici Centro de Asistencia e Investigacion Clinica Integral, Rosario, Argentina

Hospital del Centrenario, Rosario, Argentina

Fundacap Pip XII Hospital do Cancer de Barretos, Barretos, Brazil

Hospital Erasto Gaertner Liga do Combate as Cancer, Curitiba, Brazil

Associacao Hospital de Caridade Ijui, Ijui, Brazil

Hospital Sao Lucas, Porte Alegre, Brazil

Clinionco-Clinica de Oncologia de Porto Alegre, Porto Alegre, Brazil

Hospital de clinicas de Porto Alegre, Porto Alegre 90035, Brazil

Hosp.das Clinicas da Univ.de Sao Paulo, Sao Paulo, Brazil

Instituto do Cancer Aenaldo Vieira de Carvahlo, Sao Paulo, Brazil

Instituto Nacional del Cancer Oncology, Santiago, Chile

Hospital Carlos Van Buren, Valparaiso, Chile

Kidwai Memorial Institute of Oncology, Bangalore 560029, India

Apollo Speciality Hospital, Chennai 600035, India

Apollo Hospital, Hyderabad 500033, India

SEAROC Cancer Centre S.K. Soni Hospital, Jaipur 302013, India

Subodh Mitra Cancer Hospital & Research Centre, Kolkata, India

Tata Memorial Hospital, Mumbai 530002, India

Ruby Hall Clinic, Pune 411011, India

Andhra Medical College, Vishakhapatnam, India

Mayo Clinic, Scottsdale, Arizona 85259, United States

San Diego Pacific Oncology & Hematology Associates, Encinitas, California 92024, United States

Kaiser Permanente, San Diego, California 92108, United States

University San Diego Moores Cancer Center, San Diego, California 92093, United States

Premiere Oncology, Santa Monica, California 90404, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Mater Adult Hospital, South Brisbane, Queensland 4101, Australia

University Texas Health Science Center at San Antonio (CTRC), San Antonio, Texas 78229, United States

Bendigo Health Care Group, Bendigo, Victoria, Australia

Chittaranjan National Cancer Institute, Kolkata, W. Bengal 700026, India

Sir Charles Gairdner Hospital, Nedlands, Western Australia 6009, Australia

Additional Information

Starting date: February 2008
Last updated: August 15, 2011

Page last updated: August 23, 2015

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