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

August 15, 2011 updated by: Nereus Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
        • Policlínica Privada Instituto de Medicina Nuclear
      • Capital Federal, Argentina
        • Hospital Británico
      • Cordoba, Argentina, 5000 CRD
        • Instituto Oncológico de Córdoba
      • Cordoba, Argentina, 5000CRD
        • Clinica Universitaria Privada Reina Fabiola
      • Rosario, Argentina
        • Caici Centro de Asistencia e Investigacion Clinica Integral
      • Rosario, Argentina
        • Hospital del Centrenario
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Hospital
    • Victoria
      • Bendigo, Victoria, Australia
        • Bendigo Health Care Group
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Brazil
      • Barretos, Brazil
        • Fundacap Pip XII Hospital do Cancer de Barretos
      • Curitiba, Brazil
        • Hospital Erasto Gaertner Liga do Combate as Cancer
      • Ijui, Brazil
        • Associacao Hospital de Caridade Ijui
      • Porte Alegre, Brazil
        • Hospital São Lucas
      • Porto Alegre, Brazil, 90035
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Brazil
        • Clinionco-Clinica de Oncologia de Porto Alegre
      • Sao Paulo, Brazil
        • Hosp.das Clinicas da Univ.de Sao Paulo
      • Sao Paulo, Brazil
        • Instituto do Cancer Aenaldo Vieira de Carvahlo
  • Chile
      • Santiago, Chile
        • Instituto Nacional del Cancer Oncology
      • Valparaiso, Chile
        • Hospital Carlos Van Buren
  • India
      • Bangalore, India, 560029
        • Kidwai Memorial Institute of Oncology
      • Chennai, India, 600035
        • Apollo Speciality Hospital
      • Hyderabad, India, 500033
        • Apollo Hospital
      • Jaipur, India, 302013
        • SEAROC Cancer Centre S.K. Soni Hospital
      • Kolkata, India
        • Subodh Mitra Cancer Hospital & Research Centre
      • Mumbai, India, 530002
        • Tata Memorial Hospital
      • Pune, India, 411011
        • Ruby Hall Clinic
      • Vishakhapatnam, India
        • Andhra Medical College
    • W. Bengal
      • Kolkata, W. Bengal, India, 700026
        • Chittaranjan National Cancer Institute
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Encinitas, California, United States, 92024
        • San Diego Pacific Oncology & Hematology Associates
      • San Diego, California, United States, 92108
        • Kaiser Permanente
      • San Diego, California, United States, 92093
        • University San Diego Moores Cancer Center
      • Santa Monica, California, United States, 90404
        • Premiere Oncology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Texas Health Science Center at San Antonio (CTRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: docetaxel
docetaxel (75 mg/m2)
Drug: docetaxel
docetaxel (75 mg/m2)
Other Names:
  • 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 Names:
  • NPI-2358; docetaxel (Taxotere)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
Time Frame: Continuous
Continuous

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: Continuous
Continuous
Compare response rate, duration of response, 6-month survival, progression free survival and safety.
Time Frame: Continuous
Continuous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nereus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Matthew A Spear, MD, Chief Medical Officer, Nereus Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPI-2358-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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