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PHASE I FOLLOWED BY PHASE II STUDY OF THE COMBINATION OF TRASTUZUMAB EMTANSINE (T-DM1) AND CAPECITABINE IN HER2-POSITIVE METASTATIC BREAST CANCER AND HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC GASTRIC CANCER PATIENTS


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Gastric Cancer

Thank you

Trial Information

PHASE I FOLLOWED BY PHASE II STUDY OF THE COMBINATION OF TRASTUZUMAB EMTANSINE (T-DM1) AND CAPECITABINE IN HER2-POSITIVE METASTATIC BREAST CANCER AND HER2-POSITIVE LOCALLY ADVANCED OR METASTATIC GASTRIC CANCER PATIENTS


Inclusion Criteria:



Metastatic Breast Cancer Patients

- ECOG performance status of 0, 1, or 2

- Adequate blood cell count

- Adequate liver, renal and cardiac function

- Histologically or cytologically confirmed breast cancer

- Confirmed HER2-positive disease

- Metastatic breast cancer with at least one measurable lesion according to RECIST

- Disease progression on at least one regimen containing trastuzumab and chemotherapy

- Patients must have recovered from previous treatments

Metastatic Gastric Cancer Patients

- ECOG performance status of 0, 1, or 2

- Adequate blood cell count

- Adequate liver, renal and cardiac function

- Histologically or cytologically confirmed gastric cancer

- HER2-positive tumor (primary tumor or metastatic lesion)

- Inoperable locally advanced or metastatic gastric cancer

Exclusion Criteria:

- Prior treatments before first study treatment:

1. Investigational therapy within
2. Hormonal therapy within 14 days

3. Trastuzumab within 21 days

- Prior enrollment in a trastuzumab emtansine containing study, regardless of whether
the patient received prior trastuzumab emtansine

- Prior treatment with capecitabine

- History of severe and unexpected reactions to fluoropyrimidine or with known
hypersensitivity to fluorouracil

- Related capecitabine contraindications

- History of intolerance or hypersensitivity to trastuzumab or murine proteins

- History of exposure to cumulative doses of anthracyclines:

- Brain metastases that are symptomatic, or require any radiation, surgery, or steroid
therapy to control their symptoms within 28 days of first study drug administration

- Current peripheral neuropathy of Grade >/= 3 per the NCI CTCAE, v4.0

- History of other malignancy within the last 5 years, except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer,
or other cancers with a similar outcome as those mentioned above

- Current unstable ventricular arrhythmia requiring treatment

- History of symptomatic congestive heart failure (CHF) (New York Heart Association
[NYHA] Classes II-IV)

- History of myocardial infarction or unstable angina within 6 months prior to first
study drug administration

- History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab
treatment

- Severe dyspnea at rest due to complications of advanced malignancy or requiring
current continuous oxygen therapy

- Clinically significant malabsorption syndrome or inability to take oral medication

- Current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, or metabolic disease)

- Major surgical procedure or significant traumatic injury within 28 days before
enrollment or anticipation of the need for major surgery during the course of study
treatment

- Current known active infection with HIV, hepatitis B, and/or hepatitis C virus

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Maximum tolerated dose (MTD) of the combination of trastuzumab emtansine and capecitabine

Outcome Time Frame:

Up to approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Ministry of Health

Study ID:

MO28230

NCT ID:

NCT01702558

Start Date:

December 2012

Completion Date:

January 2017

Related Keywords:

  • Breast Cancer, Gastric Cancer
  • Breast Neoplasms
  • Stomach Neoplasms

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