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An Open-label, Dose-finding Study to Evaluate the Safety of AMG 706 in Combination With Paclitaxel or Docetaxel as Treatment for Locally Recurrent or Metastatic Breast Cancer

Phase 1
18 Years
Not Enrolling
Locally Recurrent and Metastatic Breast Cancer

Thank you

Trial Information

An Open-label, Dose-finding Study to Evaluate the Safety of AMG 706 in Combination With Paclitaxel or Docetaxel as Treatment for Locally Recurrent or Metastatic Breast Cancer

Inclusion Criteria:

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

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Female 18 years of age or older.

- Adequate hematologic, renal and hepatic function.

- Competent to comprehend, sign, and date an IRB-approved informed consent form.

- Subjects of childbearing potential and sexually active must provide a negative
pregnancy test and use accepted and effective method of contraception.

Exclusion Criteria:

- Prior taxane-containing treatment within 6 months prior to enrollment.

- Prior treatment including chemotherapy and/or endocrine therapy discontinued < 21
days prior to enrollment.

- More than one prior systemic chemotherapy for locally recurrent or metastatic breast

- Current or prior history of central nervous system metastases.

- History of arterial or venous thrombosis within 1 year prior to enrollment.

- History of bleeding diathesis or bleeding within 14 days prior to enrollment.

- Radiation therapy to a significant portion of bone marrow or prior history of
high-dose chemotherapy requiring bone marrow or stem cell support.

- Hypersensitivity to paclitaxel, docetaxel, or drugs using the vehicle cremophor.

- Prior VEGFr targeted therapies within 30 days of enrollment.

- Any anticoagulant therapy within 7 days prior to enrollment, except for warfarin of
less than 2mg per day.

- Clinically significant cardiac disease including myocardial infarction or other
cardiovascular related event within 1 year before enrollment.

- Uncontrolled hypertension (systolic >150 mmHg; diastolic > 90 mmHg).

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

- Prior bevacizumab or trastuzumab therapy within 12 weeks of enrollment.

- Non-healing wound, ulcer or fracture.

- Known history of prior episodes of cholecystitis, prior biliary procedure or prior or
ongoing biliary disease.

- Unable to take oral medications.

- Not recovered from previous therapies.

- Major surgery within 28 days prior to enrollment.

- Prior malignancy unless treated with curative intent and without evidence of disease
for greater than 3 years before enrollment.

- Peripheral neuropathy grade > 1 per CTCAE version 3.0

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1 of treatment. For Arm A, 1 cycle = 28 days. For Arm B, 1 cycle = 21 days

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Australia: Therapeutic Goods Administration

Study ID:




Start Date:

March 2006

Completion Date:

January 2012

Related Keywords:

  • Locally Recurrent and Metastatic Breast Cancer
  • Clinical trial
  • AMG 706
  • Anti-angiogenesis
  • Locally Recurrent
  • Metastatic
  • Breast Cancer
  • VEGF
  • Angiogenesis Inhibitor
  • Oral
  • Multi-kinase Inhibitor
  • Anti-tumor
  • PDGF receptor
  • Paclitaxel
  • Docetaxel
  • Targeted Therapy
  • Oncology
  • Amgen
  • c-Kit
  • Breast Neoplasms