Trial information
A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
Status: Completed
Protocol number: ML17263
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: An open-label pilot study of Herceptin monotherapy on objective treatment response in patients with metastatic or locally advanced gastric cancer who had disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy
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, and the target sample size is<100 individuals.
Target sample size is
20.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Gastric Cancer
Intervention type: Drug
Intervention name: trastuzumab[Herceptin]
Primary outcome: 1. Efficacy: Tumor response rate (complete and partial response)
Key secondary outcomes: 1. Efficacy: Clinical benefit rate; time to progression; duration of response; and survival
Safety: Adverse events, left ventricular ejection fraction, assessed by echocardiogram
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 08/29/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Dresden
- Erlangen
- Halle
- München
