A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00356681
• Other study ID #: 20050225
• Secondary ID: CIRG/TORI 010
• Status: Terminated
• Phase: Phase 2
• First received: July 24, 2006
• Last updated: September 24, 2015
• Start date: December 2006
• Est. completion date: August 2012

Study information

• Verified date: September 2015
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationFrance: Agence française de sécurité sanitaire des produits de santéGermany: Bundesinstitute für Arzneimittel und MedizinprodukteHong Kong: Department of HealthHungary: National Institute of PharmacyIndia: Central Drugs Standard Control OrganizationIreland: Irish Medicines BoardNew Zealand: Ministry of Health, Medicines and Medical Devices Safety AuthorityPoland: Office for Medicinal ProductsSpain: Agencia española del medicamentoUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 282
• Est. completion date: August 2012
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.

• Measurable disease by RECIST guidelines.

• Tumor (primary or metastatic) must be HER2 negative.

• Adequate organ and hematologic function. Exclusion:

• Taxane treatment within 12 months prior to registration.

• Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).

• Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.

• Current or prior history of central nervous system metastases.

• Peripheral neuropathy = grade 2 (CTCAE v3.0) at registration.

• History of arterial or venous thrombosis within 1 year prior to registration.

• History of bleeding diathesis or bleeding within 14 days of registration.

• Uncontrolled hypertension (systolic >145 mmHg; diastolic >85 mmHg).

• Clinically significant cardiac disease within 12 months of registration.

• Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.

• Prior treatment with VEGFr targeted therapies.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Tumors
• Locally Recurrent and Metastatic Breast Cancer

Intervention

Drug:
• AMG 706 placebo
Blinded placebo
• Bevacizumab
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
• AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.
• Paclitaxel
Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate, measured radiologically and assessed by an independent review committee.		Last patient enrolled + 16 weeks of treatment	No
Secondary	Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.		>24 weeks	No

External Links

•   AmgenTrials clinical trials website