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Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00322400
Recruitment Status : Completed
First Posted : May 5, 2006
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE May 4, 2006
First Posted Date  ICMJE May 5, 2006
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE March 2006
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
Incidence of dose limiting toxicities (DLTs) [ Time Frame: Cycle 1 of treatment. For Arm A, 1 cycle = 28 days. For Arm B, 1 cycle = 21 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2010)
  • Pharmacokinetics of AMG 706 when administered with paclitaxel (Arm A) or docetaxel (Arm B) [ Time Frame: Cycle 1 (Arms A and B) and Cycle 2 Arm B only) ]
  • Pharmacokinetics of paclitaxel (Arm A) when administered with AMG 706 [ Time Frame: Cycle 1, D1 and D8 for subjects in Arm A only ]
  • Pharmacokinetics of docetaxel (Arm B) when administered with AMG 706 [ Time Frame: Cycles 1 and 2 for subjects in Arm B only ]
  • Incidence of adverse events and clinical laboratory abnormalities not defined as DLTs [ Time Frame: From study entry through 30 days post discontinuation of study treatment ]
  • Objective tumor response (complete or partial response) according to modified RECIST [ Time Frame: Subjects in Arm A: every 8 weeks until discontuation. Subjects in Arm B:every 6 weeks until discontinuation. ]
  • Duration of response (calculated for those subjects who respond): time from first objective tumor response to objective disease progression or death. [ Time Frame: Subjects in Arm A: every 8 weeks until discontuation. Subjects in Arm B:every 6 weeks until discontinuation. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast Cancer
Official Title  ICMJE 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
Brief Summary This open-label, dose-finding, multi-center study is designed to determine the safety and the maximum tolerated dose of AMG 706 given once daily in combination with either weekly paclitaxel (Arm A) or once-every-3 week docetaxel (Arm B) in subjects with locally recurrent or metastatic breast cancer. Secondarily, this study will evaluate the pharmacokinetic (PK) profile of AMG 706 in both treatment arms, the PK profile of paclitaxel in Arm A and the PK profile of docetaxel in Arm B. Additionally, this study will assess objective tumor response and duration of response. Exploratory endpoints include the investigation of potential biomarker development and to assess the effects of genetic variation in drug metabolism genes, cancer genes and drug target genes on subject response to AMG 706 in combination with paclitaxel or docetaxel.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Recurrent and Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    Subjects assigned to Arm B, cohorts will receive 75 or 100 mg/m2 of docetaxel (based on cohort assignment) on Day 1 repeated every 21 days (1 cycle). AMG 706 will be administered concurrently on Days 3-21 of Cycle 1, and Days 1-21 of Cycle 2 and beyond.
  • Drug: Paclitaxel
    Subjects assigned to Arm A will receive 90 mg/m2 of paclitaxel on Days 1, 8 and 15 repeated every 28 days (1 cycle). On Arm A, AMG 706 will be concurrently administered on Days 3-28 of Cycle 1, and Days 1-28 of Cycle 2 and beyond.
  • Drug: AMG 706

    Subjects assigned to Arm A will receive AMG 706 at 50, 75, 100 or 125 mg daily (based on cohort assignment) on Days 3-28 of Cycle 1, and Days 1-28 of Cycle 2 and beyond in combination wth paclitaxel 90 mg/m2. Paclitaxel will be administered on Days 1, 8 and 15 every 28 days.

    Subjects assigned to Arm B will receive AMG 706 at 50, 75, 100 or 125 mg daily(based on cohort assignment) on Days 3-21 of Cycle 1, and Days 1-21 of Cycle 2 and beyond in combination with docetaxel. Docetaxel will be administered at either 75 mg/m2 or 100 mg/m2 on Day 1 every 21 days.

Study Arms  ICMJE
  • Experimental: B1
    AMG 706 50 mg daily + Docetaxel (100 mg/m2 D1 every 21 days)
    Interventions:
    • Drug: Docetaxel
    • Drug: AMG 706
  • Experimental: A4
    75 mg AMG 706 daily + Paclitaxel (90 mg/m2 on D1, D8 and D15 every 28 days)
    Interventions:
    • Drug: Paclitaxel
    • Drug: AMG 706
  • Experimental: A1
    AMG 706 50 mg daily + Paclitaxel (90 mg/m2 D1, D8, D15 every 28 days)
    Interventions:
    • Drug: Paclitaxel
    • Drug: AMG 706
  • Experimental: B4
    75 mg AMG 706 daily + Docetaxel (100 mg/m2, D1 every 21 days)
    Interventions:
    • Drug: Docetaxel
    • Drug: AMG 706
  • Experimental: B5
    MTD of AMG 706 + Docetaxel (75mg/m2 D1 every 21 days)
    Interventions:
    • Drug: Docetaxel
    • Drug: AMG 706
  • Experimental: B3
    100 mg AMG 706 daily + Docetaxel (100 mg/m2 on D1 every 21 days)
    Interventions:
    • Drug: Docetaxel
    • Drug: AMG 706
  • Experimental: B2
    AMG 706 125 mg daily + Docetaxel (100 mg/m2 D1 every 21 days)
    Interventions:
    • Drug: Docetaxel
    • Drug: AMG 706
  • Experimental: A2
    AMG 706 125 mg daily + paclitaxel 90 mg/m2 D1, D8, D15 every 28 days
    Interventions:
    • Drug: Paclitaxel
    • Drug: AMG 706
  • Experimental: A3
    100 mg AMG 706 daily + Paclitaxel (90 mg/m2 on D1, D8, and D15 every 28 days)
    Interventions:
    • Drug: Paclitaxel
    • Drug: AMG 706
Publications * De Boer RH, Kotasek D, White S, Koczwara B, Mainwaring P, Chan A, Melara R, Ye Y, Adewoye AH, Sikorski R, Kaufman PA. Phase 1b dose-finding study of motesanib with docetaxel or paclitaxel in patients with metastatic breast cancer. Breast Cancer Res Treat. 2012 Aug;135(1):241-52. doi: 10.1007/s10549-012-2135-0. Epub 2012 Jul 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2008)
46
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 cancer.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   United States
 
Administrative Information
NCT Number  ICMJE NCT00322400
Other Study ID Numbers  ICMJE 20050200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP