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A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00369070
First received: August 24, 2006
Last updated: June 9, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.

Condition Intervention Phase
Advanced Non-squamous NSCLC
Biological: Bevacizumab
Drug: AMG 706
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Objective tumor response rate [ Time Frame: Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Time Frame: Time from first objective tumor response to disease progression or death, if the death was due to disease progression. ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Number of days from randomization tot he date of radiological evidence of disease progression or death. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Time from randomization to death. ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B [ Time Frame: From randomization until disease progression or death. ] [ Designated as safety issue: Yes ]
  • Safety and tolerability in the 3 arms [ Time Frame: From randomization until disease progression or death. ] [ Designated as safety issue: Yes ]

Enrollment: 186
Study Start Date: January 2007
Arms Assigned Interventions
Experimental: A
AMG 706 125 mg once daily (QD) and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
Drug: AMG 706
subjects in Arms A and B will take AMG 706 orally in one of two dosing regimens over each 21-day cycle: •Arm A: 125 mg once daily (QD) •Arm B: 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days
Other Name: Motesanib diphosphate
Drug: Paclitaxel
All subjects will receive a paclitaxel chemotherapy regimen (paclitaxel 200 mg/m2) on day 1 of each 3-week cycle for a maximum of 6 cycles.
Drug: Carboplatin
All subjects will receive carboplatin chemotherapy regimen (carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3-week cycle for a maximum of 6 cycles.
Experimental: B
AMG 706 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
Drug: AMG 706
subjects in Arms A and B will take AMG 706 orally in one of two dosing regimens over each 21-day cycle: •Arm A: 125 mg once daily (QD) •Arm B: 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days
Other Name: Motesanib diphosphate
Drug: Paclitaxel
All subjects will receive a paclitaxel chemotherapy regimen (paclitaxel 200 mg/m2) on day 1 of each 3-week cycle for a maximum of 6 cycles.
Drug: Carboplatin
All subjects will receive carboplatin chemotherapy regimen (carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3-week cycle for a maximum of 6 cycles.
Active Comparator: C
Bevacizumab 15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
Biological: Bevacizumab
15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks
Other Name: Avastin
Drug: Paclitaxel
All subjects will receive a paclitaxel chemotherapy regimen (paclitaxel 200 mg/m2) on day 1 of each 3-week cycle for a maximum of 6 cycles.
Drug: Carboplatin
All subjects will receive carboplatin chemotherapy regimen (carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3-week cycle for a maximum of 6 cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00369070

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00369070     History of Changes
Other Study ID Numbers: 20060136 
Study First Received: August 24, 2006
Last Updated: June 9, 2016
Health Authority: Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Western Institutional Review Board

Keywords provided by Amgen:
AMG 706
Bevacizumab
Paclitaxel and Carboplatin
Randomized
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Bevacizumab
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Niacinamide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on December 08, 2016