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NCT01191697 · ClinicalTrials.gov registry record · Phase 2
CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT01191697: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01191697 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01191697, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab. Trastuzumab (also called Herceptin) is an antibody that attacks HER2 protein in tumor cells. Bevacizumab (also called Avastin) works by slowing or stopping the growth of cells in cancer tumors by decreasing the blood supply of the tumors. If blood supply is decreased, oxygen and nutrients that are needed for tumor growth are decreased. The chemotherapy used in this trial is called CAPOX, which is an abbreviation of capecitabine and oxaliplatin.
Primary Outcome
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and a
Interventions
- DRUG bevacizumab
- DRUG trastuzumab
- DRUG oxaliplatin
- DRUG capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-02 |
| Est. Completion | 2024-08 |
| Phase | Phase 2 |
What the finished NCT01191697 record still lists
NCT01191697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which bevacizumab is the first listed.
NCT01191697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01191697 about?
NCT01191697 is a clinical study titled "CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer". The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy, capecitabine and oxaliplatin, plus the antibodies bevacizumab and trastuzumab. Trastuzumab (also called Herceptin) is an antibody that attacks HER2 protein in tumor cells. Bevacizumab (also calle...
What is the current status of trial NCT01191697?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2011-02. Estimated completion is 2024-08.
What interventions are being tested in trial NCT01191697?
The interventions under investigation include: bevacizumab (DRUG), trastuzumab (DRUG), oxaliplatin (DRUG), capecitabine (DRUG).
Who is sponsoring clinical trial NCT01191697?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01191697's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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