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
ClinicalTrials.gov Identifier:
NCT00480831
First received: May 30, 2007
Last updated: January 17, 2013
Last verified: January 2013

May 30, 2007
January 17, 2013
June 2007
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
Progression-free survival
Complete list of historical versions of study NCT00480831 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Objective response
  • Duration of objective response
  • Overall survival
  • Incidence, nature, and severity of adverse events
  • Changes in vital signs, physical findings, and clinical laboratory results during and following Apomab administration
  • Apomab maximum serum concentration (Cmax)
  • Apomab minimum serum concentration (Cmin)
  • Cmax and Cmin for carboplatin, bevacizumab, and paclitaxel and its major metabolite
Not Provided
Not Provided
 
A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: carboplatin
    Intravenous repeating dose
  • Drug: paclitaxel
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
  • Drug: PRO95780
    Intravenous repeating dose
  • Experimental: 1
    Interventions:
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: PRO95780
  • Placebo Comparator: 2
    Interventions:
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
Not Provided
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00480831
APM4074g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Gordon Bray, M.D. Genentech
Genentech
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP