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 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).Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.1Level: LLTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2012-000660-22-ES
- Lead Sponsor
- F. Hoffmann?La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 412
? Adult patients >/=18 years of age
? Histologically or cytologically confirmed Her2+ AGC (advanced gastric cancer) and must have experienced documented objective
radiographic or pathologic disease progression during or after first-line therapy for their disease.
? must have received at least one prior chemotherapy regimen for
AGC; prior therapy 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:
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 prior to commencing study treatment ? 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: ? Phase II: To select a trastuzumab emtansine dose and schedule for Phase III assessment. ? Phase III: To compare the overall survival (OS) of patients treated with trastuzumab emtansine to that of patients treated with physician?s choice of taxane (docetaxel or paclitaxel).;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, irrespective of the cause of death.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Tumor response endpoints - Progression-Free Survival - Objective Response;Timepoint(s) of evaluation of this end point: - Progression-Free Survival: the time from the date of randomization to the date of first occurrence of PD or death from any cause, whichever occurs first. - Objective Response?the achievement of a best overall response of PR or CR.