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

NCT00356681 | Terminated Phase 2 DMC

• 2 other identifiers: 20050225CIRG/TORI 010
• Study Type: interventional
• Target: 282
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

AMG 706; Paclitaxel; Metastatic Breast Cancer; Antiangiogenic; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate, measured radiologically and assessed by an independent review committee.

  Last patient enrolled + 16 weeks of treatment

Secondary Outcomes (1)

• 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

Study Arms (3)

Arm A Placebo

PLACEBO COMPARATOR

Blinded AMG 706 placebo plus paclitaxel

Drug: AMG 706 placebo; Drug: Paclitaxel

Arm B Experimental

EXPERIMENTAL

Blinded AMG 706 plus paclitaxel

Drug: AMG 706; Drug: Paclitaxel

Arm C Comparator

ACTIVE COMPARATOR

Open-label bevacizumab plus paclitaxel

Drug: Bevacizumab; Drug: Paclitaxel

Interventions

AMG 706 placebo DRUG

Blinded placebo

Arm A Placebo

Bevacizumab DRUG

Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.

Also known as: Avastin

Arm C Comparator

AMG 706 DRUG

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.

Also known as: motesanib diphosphate

Arm B Experimental

Paclitaxel DRUG

Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.

Arm A Placebo; Arm B Experimental; Arm C Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagiello-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Banos A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010 investigators. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011 Apr;12(4):369-76. doi: 10.1016/S1470-2045(11)70037-7. Epub 2011 Mar 21.

  PMID: 21429799 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; motesanib diphosphate; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 26, 2006
• Study Start: December 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: August 1, 2012
• Last Updated: October 15, 2015

Record last verified: 2015-09