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Study Complete
Sponsor ID
20062042

Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer

Sponsor ID
20062042
Clinicaltrials.gov ID
NCT00807859
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer.

This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.

Additional Study Details

Phase
Phase 1
Product
AMG 386
Type
Interventional
Masking
None (Open Label)
Enrollment
65
Additional Study Details

Protocol Summary

Primary Outcome Measures

Primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as a dose limiting toxicity in subjects treated with AMG 386 plus paclitaxel and trastuzumab or with AMG 386 plus capecitabine and lapatinib

Timeframe: 24 months

Secondary Outcome Measures

To evaluate the incidence of adverse events and clinical laboratory abnormalities not defined as DLTs

Timeframe: 24 months

To evaluate the pharmacokinetics (PK) of AMG 386, trastuzumab, and paclitaxel (cohort A) or AMG 386, lapatinib, and capecitabine (and its active metabolite, 5-FU; cohort B) when administered in combination

Timeframe: 24 months

To estimate the incidence of anti AMG 386 antibody formation

Timeframe: 24 months

To evaluate the treatment effect as measured by the following: objective response rate (ORR), duration of response (DOR), change in tumor burden and progression-free survival (PFS)

Timeframe: 23 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Tucson, AZ, United States, 85724
Status
Recruiting
Location
Research Site
Iowa City, IA, United States, 52242
Status
Completed
Location
Research Site
Boston, MA, United States, 02111
Status
Completed
Location
Research Site
Middletown, OH, United States, 45042
Status
Recruiting
Location
Research Site
New City, NY, United States, 10956
Status
Completed
Location
Research Site
Lebanon, NH, United States, 03756
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Breast Cancer
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  • Cancer - Other
  • Advanced/Metastatic Cancer
  • Solid Tumor
  • Tumor
    • Sex
    Assigned Female at Birth
    Trial Dates
    Mar 2009 - Feb 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease not amenable to any local treatment with curative intent. - HER2-positive by FISH, CISH, or IHC 3+ - ECOG performance status 0 or 1 - Left ventricular ejection fraction greater than or equal to institutional lower limit of normal - Adequate laboratory studies (hematological, chemistries and urinalysis) - Life expectancy greater than or equal to 3 months - Cohort A only: - Trastuzumab naïve or trastuzumab in the neo-adjuvant setting - No clinically significant drop in cardiac function prior exposure to trastuzumab -No prior chemotherapy for metastatic or locally recurrent breast cancer - No prior lapatinib therapy - At least 3 weeks from enrollment since prior chemotherapeutic agents, including taxanes, in the neoadjuvant or adjuvant setting - At least 3 months from enrollment since prior trastuzumab in the neoadjuvant or adjuvant setting - Cohort B only: - Must have failed trastuzumab in the first-line metastatic setting. Trastuzumab must be discontinued for at least 3 weeks prior to enrollment - Must have received prior chemotherapy as adjuvant therapy or for metastatic disease - Prior chemotherapy treatment must be discontinued for at least 3 weeks prior to enrollment - No prior capecitabine - No prior lapatinib
    Exclusion Criteria:
    - Inflammatory breast cancer - Central nervous system metastasis - Clinically significant cardiovascular disease - Radiation therapy ≤ 14 days prior to enrollment. - Concurrent anticoagulation therapy, excluding aspirin, anti-platelet agents, low molecular weight heparin or low dose warfarin per protocol. -Uncontrolled hypertension defined as diastolic blood pressure > 90 mmHg OR systolic blood pressure > 140 mmHg. - Subjects with a history of prior malignancy, except: - For Cohort B only: - Current or prior history of long QT syndrome - Baseline ECG report of QTc interval of > 480 milliseconds - Severe chronic liver disease (Child Pugh C)