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NCT01774786 · ClinicalTrials.gov registry record · Phase 3
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
A Phase 3 study of Gastric Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 780
- Enrollment target
- 20
- Study locations
NCT01774786 is a Phase 3 study of Gastric Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 780 participants, above the 314-participant average among 153 other Gastric Cancer trials with a reported enrollment target (148% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT01774786, a Phase 3 study of Gastric Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 780 participants
- Enrollment target
- 20
- Study locations
Study Summary
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram \[mg/kg\] intravenously \[IV\] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG 5-Fluorouracil
- DRUG Pertuzumab
Study Locations (20)
New York
- New York Oncology Hematology, P.C. - Albany
- Queens Medical Associates - Fresh Meadows
- Weill Medical College of Cornell University; Division of Hematology & Medical Oncology - New York
Other
- Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. - Salzburg
- Krankenhaus St. Vinzenz Der Barmherzigen Schwestern Zams; Abt. Für Innere Medizin - Zams
- Cliniques Universitaires St-Luc - Brussels
Victoria
- Monash Medical Centre; Oncology - Clayton
- Austin Health; Cancer Clinical Trial Centre - Heidelberg
Rio Grande do Sul
- Hospital Nossa Senhora da Conceicao - Porto Alegre
- Hospital das Clinicas - UFRGS - Porto Alegre
Florida
- Florida Cancer Specialists - SCRI; Pharmacy - Fort Myers
Illinois
- University Of Chicago Medical Center; Section Of Hematology/Oncology - Chicago
Indiana
- Indiana University Health; Goshen Center for Cancer Care - Goshen
Nevada
- Comprehensive Cancer Centers of Nevada - Eastern Avenue - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2013-06-10 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01774786
The ClinicalTrials.gov registry entry for NCT01774786 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 780 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 314-participant average among 153 other Gastric Cancer trials with a reported enrollment target (148% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01774786 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Other, Victoria.
Frequently Asked Questions
What is clinical trial NCT01774786 about?
NCT01774786 is a clinical study titled "A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer". This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal...
What is the current status of trial NCT01774786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 780 participants. The study started on 2013-06-10. Estimated completion is 2019-12-31.
What conditions does trial NCT01774786 study?
This clinical trial studies the following conditions: Gastric Cancer.
What interventions are being tested in trial NCT01774786?
The interventions under investigation include: Placebo (DRUG), Capecitabine (DRUG), Cisplatin (DRUG), 5-Fluorouracil (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT01774786?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01774786 being conducted?
This trial has 20 study locations across Florida, Illinois, Indiana, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.