Study of Vismodegib in Advanced Gastric Adenocarcinoma Patients With SMO Overexpression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03052478|
Recruitment Status : Active, not recruiting
First Posted : February 14, 2017
Last Update Posted : May 20, 2019
There is no accepted standard therapy for patients with advanced gastric cancer who have progressed during or after second-line therapy. The role of 3rd line treatment in advanced gastric cancer has not been proven.
As a novel target of gastric cancer, SMO overexpression is chosen in this study, and the investigators plan this study to evaluate the efficacy and safety of vismodegib in gastric cancer. The doses of vismodegib are based on trials of basal cell carcinoma.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms||Drug: Vismodegib 150 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Single-arm Study of Vismodegib in Advanced Gastric Adenocarcinoma Patients With SMO Overexpression|
|Actual Study Start Date :||February 10, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: vismodegib arm
. Vismodegib 150 mg will be administered orally once a day for 21 days as one cycle.
Drug: Vismodegib 150 mg
Vismodegib 150 mg will be administered orally once a day for 21 days as one cycle.
- Objective response rate (ORR) by RECIST 1.1 [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052478
|Korea, Republic of|
|Samsung Medical Center|
|Seoul City, Seoul, Korea, Republic of, 135710|
|Principal Investigator:||Jeeyun Lee, MD, PhD||Division of Hematology-Oncology, SMC|