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Sponsor ID
20050200

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

Sponsor ID
20050200
Clinicaltrials.gov ID
NCT00322400
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
motesanib diphosphate
Type
Interventional
Masking
None (Open Label)
Enrollment
46
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of dose limiting toxicities (DLTs)

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

Secondary Outcome Measures

Pharmacokinetics of AMG 706 when administered with paclitaxel (Arm A) or docetaxel (Arm B)

Timeframe: Cycle 1 (Arms A and B) and Cycle 2 Arm B only)

Pharmacokinetics of paclitaxel (Arm A) when administered with AMG 706

Timeframe: Cycle 1, D1 and D8 for subjects in Arm A only

Pharmacokinetics of docetaxel (Arm B) when administered with AMG 706

Timeframe: Cycles 1 and 2 for subjects in Arm B only

Incidence of adverse events and clinical laboratory abnormalities not defined as DLTs

Timeframe: From study entry through 30 days post discontinuation of study treatment

Objective tumor response (complete or partial response) according to modified RECIST

Timeframe: 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.

Timeframe: Subjects in Arm A: every 8 weeks until discontuation. Subjects in Arm B:every 6 weeks until discontinuation.

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Breast Cancer
    • Sex
    Assigned Female at Birth
    Trial Dates
    Mar 2006 - Apr 2009
    Inclusion and Exclusion Criteria
    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