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

Roche

Status and phase: Terminated; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005484

ML17263

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Trastuzumab Monotherapy

Experimental group

Description:

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

Treatment:

Drug: Trastuzumab