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
Sponsor study identifier
interventional
46
0 countries
N/A
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Actual (reported)Study Completion
January 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
May 4, 2006
Actual (reported)May 5, 2006
Actual (reported)April 2009
Actual (reported)January 2012
Actual (reported)Incidence of dose limiting toxicities (DLTs)
Cycle 1 of treatment. For Arm A, 1 cycle = 28 days. For Arm B, 1 cycle = 21 days
Pharmacokinetics of AMG 706 when administered with paclitaxel (Arm A) or docetaxel (Arm B)
Cycle 1 (Arms A and B) and Cycle 2 Arm B only)
Pharmacokinetics of paclitaxel (Arm A) when administered with AMG 706
Cycle 1, D1 and D8 for subjects in Arm A only
AMG 706 50 mg daily + Docetaxel (100 mg/m2 D1 every 21 days)
75 mg AMG 706 daily + Paclitaxel (90 mg/m2 on D1, D8 and D15 every 28 days)
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.
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.
MD
Amgen
46 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2006
First Posted
May 5, 2006
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacokinetics of docetaxel (Arm B) when administered with AMG 706
Cycles 1 and 2 for subjects in Arm B only
Incidence of adverse events and clinical laboratory abnormalities not defined as DLTs
From study entry through 30 days post discontinuation of study treatment
Objective tumor response (complete or partial response) according to modified RECIST
Subjects in Arm A: every 8 weeks until discontuation. Subjects in Arm B:every 6 weeks until discontinuation.
AMG 706 50 mg daily + Paclitaxel (90 mg/m2 D1, D8, D15 every 28 days)
75 mg AMG 706 daily + Docetaxel (100 mg/m2, D1 every 21 days)
MTD of AMG 706 + Docetaxel (75mg/m2 D1 every 21 days)
100 mg AMG 706 daily + Docetaxel (100 mg/m2 on D1 every 21 days)
AMG 706 125 mg daily + Docetaxel (100 mg/m2 D1 every 21 days)
AMG 706 125 mg daily + paclitaxel 90 mg/m2 D1, D8, D15 every 28 days
100 mg AMG 706 daily + Paclitaxel (90 mg/m2 on D1, D8, and D15 every 28 days)
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.
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.
Contact the study team to confirm eligibility.
Primary Completion
April 2009
Actual (reported)Study Completion
January 2012
Actual (reported)Last Updated
July 31, 2013
Record last verified: 2013-07
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