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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480831
• Other study ID #: APM4074g
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2007
• Last updated: May 16, 2017
• Start date: June 2007
• Est. completion date: August 2010

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• bevacizumab
Intravenous repeating dose
• carboplatin
Intravenous repeating dose
• paclitaxel
Intravenous repeating dose
• placebo
Intravenous repeating dose
• PRO95780
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		Length of study
Primary	Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration		Length of study
Primary	Progression-free survival, as determined by independent review facility		Length of study
Secondary	Objective response and duration of response, as determined by independent review facility		Length of study
Secondary	Overall survival		24 months
Secondary	Progression-free survival, objective response, and duration of objective response, as determined by the investigator		Length of study
Secondary	Pharmacokinetic parameters		Length of study