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

Advanced Non-squamous NSCLC Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00369070
• Other study ID #: 20060136
• Status: Terminated
• Phase: Phase 2
• First received: August 24, 2006
• Last updated: January 2, 2018
• Start date: January 31, 2007
• Est. completion date: August 3, 2011

Study information

• Verified date: January 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 186
• Est. completion date: August 3, 2011
• Est. primary completion date: April 23, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Non-squamous NSCLC

Intervention

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

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
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

Blumenschein GR Jr, Kabbinavar F, Menon H, Mok TS, Stephenson J, Beck JT, Lakshmaiah K, Reckamp K, Hei YJ, Kracht K, Sun YN, Sikorski R, Schwartzberg L; Motesanib NSCLC Phase II Study Investigators. A phase II, multicenter, open-label randomized study of motesanib or bevacizumab in combination with paclitaxel and carboplatin for advanced nonsquamous non-small-cell lung cancer. Ann Oncol. 2011 Sep;22(9):2057-67. doi: 10.1093/annonc/mdq731. Epub 2011 Feb 14. — View Citation

Claret L, Lu JF, Bruno R, Hsu CP, Hei YJ, Sun YN. Simulations using a drug-disease modeling framework and phase II data predict phase III survival outcome in first-line non-small-cell lung cancer. Clin Pharmacol Ther. 2012 Nov;92(5):631-4. doi: 10.1038/clpt.2012.78. Epub 2012 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response rate		Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.
Secondary	Duration of response		Time from first objective tumor response to disease progression or death, if the death was due to disease progression.
Secondary	Progression free survival		Number of days from randomization tot he date of radiological evidence of disease progression or death.
Secondary	Overall survival		Time from randomization to death.
Secondary	Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B		From randomization until disease progression or death.
Secondary	Safety and tolerability in the 3 arms		From randomization until disease progression or death.

External Links

•   AmgenTrials clinical trials website