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

January 2, 2018 updated by: Amgen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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.
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.
Biological: Bevacizumab
15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective tumor response rate
Time Frame: Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.
Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: Time from first objective tumor response to disease progression or death, if the death was due to disease progression.
Time from first objective tumor response to disease progression or death, if the death was due to disease progression.
Progression free survival
Time Frame: Number of days from randomization tot he date of radiological evidence of disease progression or death.
Number of days from randomization tot he date of radiological evidence of disease progression or death.
Overall survival
Time Frame: Time from randomization to death.
Time from randomization to death.
Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B
Time Frame: From randomization until disease progression or death.
From randomization until disease progression or death.
Safety and tolerability in the 3 arms
Time Frame: From randomization until disease progression or death.
From randomization until disease progression or death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2007

Primary Completion (Actual)

April 23, 2008

Study Completion (Actual)

August 3, 2011

Study Registration Dates

First Submitted

August 24, 2006

First Submitted That Met QC Criteria

August 24, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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