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

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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

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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