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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2011-08-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Non-squamous NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

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.

Carboplatin

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

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.

Carboplatin

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type BIOLOGICAL

15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks

Paclitaxel

Intervention Type DRUG

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.

Carboplatin

Intervention Type DRUG

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.

Interventions

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Bevacizumab

15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks

Intervention Type BIOLOGICAL

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Avastin Motesanib diphosphate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No