Clinical trial · Interventional
A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to slow patient recruitment.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab Monotherapy
- description
- Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
- interventionNames
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
- timeFrame
- Weekly throughout study
- description
- Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\]10 millimeters \[mm\]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available