A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer.

Phase 1

• Conditions: Human Epidermal growth factor Receptor 2 (HER2) positive locally advanced or metastatic Gastric Cancer (GC), including adenocarcinoma of the gastroesophageal junction (GEJ).; MedDRA version: 18.0Level: PTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000660-22-DE
• Lead Sponsor: F. Hoffmann–La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-27
• Last Update Posted: 21 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• Adult patients, aged >/= 18 years.
• ECOG performance status of 0 or 1.
• Life expectancy of at least 12 weeks from the first dose of study treatment.
• Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization.
• Patients must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease.
• HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization).
• Patients must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy.
• First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy.
• Adjuvant or neoadjuvant therapy for AGC is allowed.
• Women of childbearing potential and men with partners of childbearing potential must be willing to use a highly effective, non-hormonal form of contraception or two effective forms of contraception by the patient and/or partner and continue its use for the duration of study treatment and for 7 months after the last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 232
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

• An interval shorter than 21 days from the last dose of chemotherapy or
HER2-directed therapy until the time of randomization.
• Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel
either as single agents or as part of a treatment regimen.
• Treatment with any investigational anticancer drug within 21 days of
the first study treatment administration.
• More than one prior line of therapy for advanced gastric cancer.
• History of other malignancy within the previous 5 years except for
appropriately treated carcinoma in situ of the cervix, non-melanoma skin
carcinoma, Stage I uterine cancer, or other malignancies with an
expected curative outcome.
• Brain metastases that are untreated or symptomatic or require any
radiation, surgery, or steroid therapy to control symptoms from brain
metastases within 1 month of randomization.
• Peripheral neuropathy Grade >/=2.
• Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure,
serious cardiac arrhythmia).
• Other current, severe, uncontrolled systemic disease (e.g., clinically
significant metabolic disease, wound healing disorders, ulcers).
• Clinically significant bleeding within 30 days before enrollment.
• For female patients, current pregnancy or lactation.
• Major surgical procedure or significant traumatic injury within 28 days
prior to randomization or anticipation of the need for major surgery
during the course of study treatment.
• Infection with HIV or hepatitis B virus, hepatitis C virus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified