A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

NCT ID: NCT02005484

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-02-29

Brief Summary

This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab Monotherapy

Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

4 mg/kg initial dose, followed by 2 mg/kg

Interventions

Trastuzumab

4 mg/kg initial dose, followed by 2 mg/kg

Intervention Type: DRUG

Other Intervention Names

Herceptin

Eligibility Criteria

Inclusion Criteria

• adult patients 18-75 years of age;
• metastatic or advanced gastric cancer;
• disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
• >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
• >=1 measurable lesion;
• HER2 overexpression (IHC [2+] or [3+]).

Exclusion Criteria

• concurrent chemotherapy or immunotherapy;
• brain or meningeal metastases;
• clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
• co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
• women who are pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Vienna, , Austria

Dresden, , Germany

Erlangen, , Germany

Essen, , Germany

Grenzach-Wyhlen, , Germany

Halle, , Germany

Kassel, , Germany

Kiel, , Germany

Mannheim, , Germany

München, , Germany

München, , Germany

Oldenburg, , Germany

Countries

Austria; Germany

Other Identifiers

ML17263

Identifier Type: -

Identifier Source: org_study_id