A study to evaluate the efficacy and safety of trastuzumab emtansine compared to a taxane (docetaxel or paclitaxel), in patients with previously treated gastric cancer that has spread to other tissues, including adenocarcinoma of the gastroesophageal junction.
- 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: 14.1Level: PTClassification code 10061968Term: Gastric neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000660-22-IT
- Lead Sponsor
- F. HOFFMANN - LA ROCHE LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 412
• Adult patients =18 years of age
• Histologically or cytologically confirmed Her2+ AGC defined as
unresectable and locally advanced or metastatic gastric cancer, including
adenocarcinoma of the GEJ, and must have experienced documented
objective radiographic or pathologic disease progression during or after
first-line therapy for their disease.
• First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum (e.g., cisplatin,
carboplatin, or oxaliplatin) AND a fluoropyrimidine (e.g., 5-FU,capecitabine, or S-1) given concurrently; prior therapy can but does not need to have included HER2-directed therapy.
• Patients must have measurable and/or non-measurable disease which
must be evaluable per RECIST 1.1
• ECOG Performance Status 0 or 1
• Adequate organ function as determined by laboratory results.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
• 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. Prior
treatment with trastuzumab, lapatinib, or pertuzumab is allowed
• Treatment with any anticancer investigational drug within 21 days of
the first study treatment administration.
• 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
• Inadequate cardiopulmonary function.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the overall survival (OS) of patients treated with<br>trastuzumab emtansine with the regimen from Stage 1 of the study<br>selected at the interim analysis to the OS of patients treated with<br>physician's choice of taxane (docetaxel or paclitaxel) in patients with HER2-positive advanced gastric cancer (AGC), defined as unresectable<br>and locally advanced or metastatic GC, including adenocarcinoma of the<br>GEJ.;Secondary Objective: • Objective response rate (ORR)<br>• Progression-free survival (PFS)<br>• Duration of response (DOR)<br>• Characterization of clinical safety<br>• Assessment of Quality of Life;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: The time from the date of randomization to the date of death,<br>irrespective of the cause of death
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Endpoint di risposta tumorale:<br>- Sopravvivenza libera da progressione<br>- Risposta Obiettiva;Timepoint(s) of evaluation of this end point: - Progression-Free Survival: the time from the date of randomization to<br>the date of first occurrence of PD or death from any cause, whichever<br>occurs first.<br>- Objective Response:the achievement of a best overall response of PR<br>or CR.