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A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-squamous Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Non-squamous NSCLC

Thank you

Trial Information

A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-squamous Non-small Cell Lung Cancer


Inclusion Criteria:



- Men or women 18 years or older with histologically or cytologically confirmed
advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural
effusion or stage IV/recurrent)

- Measureable disease per RECIST criteria modified

- ECOG performance status of 0 or 1

- Ability to take oral medications

- Competent to give written informed consent

Exclusion Criteria:

- Current or prior history of CNS metastases

- Any prior chemotherapy for advanced NSCLC

- History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to
randomization

- Prior targeted therapies

- Known history of allergy or hypersensitivity to paclitaxel or carboplatin

- History of arterial or venous thrombosis within 52 weeks prior to randomization

- History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to
randomization

- Peripheral neuropathy > grade 1 per CTCAE Version 3.0

- Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral
vascular disease, transient ischemic attack, congestive heart failure, percutaneous
transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or
unstable angina within 52 weeks prior to randomization

- Any kind of disorder that compromises the ability of the subject to comply with the
study procedures

- Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg.
Anti-hypertensive medications are allowed if hypertension is stably controlled at the
time of randomization.

- Participation in therapeutic clinical trials or currently receiving other
investigational treatment(s) within 30 days prior to randomization

- Pregnant or breast feeding women

- Known to be HIV, hepatitis B surface antigen, or hepatitis C positive

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective tumor response rate

Outcome Time Frame:

Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Hong Kong: Department of Health

Study ID:

20060136

NCT ID:

NCT00369070

Start Date:

July 2007

Completion Date:

August 2011

Related Keywords:

  • Advanced Non-squamous NSCLC
  • AMG 706
  • Bevacizumab
  • Paclitaxel and Carboplatin
  • Randomized
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung

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