RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
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|ClinicalTrials.gov Identifier: NCT00729482|
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : February 13, 2014
Last Update Posted : November 27, 2018
This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.
Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy.
Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. Treatment will be continued until disease progression or patient's intolerability to the study drug.
Total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasm||Drug: RAD001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||March 2013|
Treatment Arm (RAD001)
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Other Name: everolimus
- Progression-free Survival Rate at 4-month (16 Weeks) [ Time Frame: 4 months (16 weeks) ]progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
- Response Rate [ Time Frame: 2years ]Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.
- Overall Survival [ Time Frame: 1 year ]
- Number of Participants With Adverse Events [ Time Frame: up to 24 weeks ](according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)
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): NCT00729482
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Songpa, Korea, Republic of, 138-736|