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NCT01450696 · ClinicalTrials.gov registry record · Phase 3
A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 296
- Enrollment target
NCT01450696 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 296 participants.
The verdict
NCT01450696, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 296 participants
- Enrollment target
Study Summary
This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. Participants who have not received prior treatment for metastatic disease will be randomized to receive Herceptin intravenously as either an 8-milligram per kilogram (mg/kg) loading dose followed by 6 mg/kg every 3 weeks (q3w) as standard of care or an 8-mg/kg loading dose followed by 10 mg/kg q3w until disease progression. Capecitabine will be administered for 6 cycles at a dose of 800 milligrams per meter-squared (mg/m\^2) orally twice a day on Days 1 to 14 of each 3-week cycle, and cisplatin will be administered intravenously for 6 cycles at a dose of 80 mg/m\^2 on Day 1 of each 3-week cycle. Herceptin will be continued until disease progression occurs.
Interventions
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG Herceptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01450696
The ClinicalTrials.gov registry entry for NCT01450696 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT01450696 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01450696 about?
NCT01450696 is a clinical study titled "A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer". This randomized, open-label, multicenter, international Phase IIIb study will compare the efficacy and safety of two Herceptin dosing regimens in combination with cisplatin/capecitabine chemotherapy in participants with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma. P...
What is the current status of trial NCT01450696?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2011-12. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01450696?
The interventions under investigation include: Capecitabine (DRUG), Cisplatin (DRUG), Herceptin (DRUG).
Who is sponsoring clinical trial NCT01450696?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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