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A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00480831
First received: May 30, 2007
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab
Drug: carboplatin
Drug: paclitaxel
Drug: placebo
Drug: PRO95780
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Progression-free survival, as determined by independent review facility [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response and duration of response, as determined by independent review facility [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Progression-free survival, objective response, and duration of objective response, as determined by the investigator [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: June 2007
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: PRO95780
Intravenous repeating dose
Placebo Comparator: 2 Drug: bevacizumab
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

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

Inclusion Criteria:

  • Ability to understand and willingness to sign a written informed consent
  • Histologically or cytologically confirmed NSCLC
  • Advanced NSCLC
  • Measurable disease
  • ECOG performance status of 0 or 1
  • Age ≥ 18 years
  • Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men

Exclusion Criteria:

  • Squamous cell histology
  • Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization
  • Untreated or unstable CNS metastases
  • Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization
  • Uncontrolled hypertension
  • History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization
  • Major surgical procedure within 28 days prior to randomization
  • Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization
  • Persistent history of gross hemoptysis relating to the patient's NSCLC
  • Known HIV infection
  • Known to be positive for hepatitis C or hepatitis B surface antigen
  • Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function
  • Use of anticoagulation therapy
  • Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization
  • Pregnancy (e.g., positive HCG test) or breast feeding
  • Known sensitivity to any of the products to be administered during the study
  • Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures
  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: NCT00480831

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Gordon Bray, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00480831     History of Changes
Other Study ID Numbers: APM4074g
Study First Received: May 30, 2007
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
NSCLC
Cancer
Avastin
APM4074g

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Carboplatin
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014