RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yoon-Koo Kang, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT00729482

First received: August 4, 2008

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 4, 2008
Last Updated Date	August 1, 2012
Start Date ^ICMJE	July 2008
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 4, 2008)	progression-free survival rate at 4-month (16 weeks) [ Time Frame: 4 months (16 weeks) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00729482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 14, 2012)	response rate [ Time Frame: 2years ] [ Designated as safety issue: No ] Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ] Toxicity profiles (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 4, 2008)	response rate [ Time Frame: no time frame (best response) ] [ Designated as safety issue: No ] overall survival [ Designated as safety issue: No ] toxicities [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
Official Title ^ICMJE	A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer
Brief Summary	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%.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Stomach Neoplasm
Intervention ^ICMJE	Drug: RAD001 RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability Other Name: everolimus
Study Arm (s)	Experimental: 1 Treatment Arm (RAD001) Intervention: Drug: RAD001
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	54
Completion Date	April 2012
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination) Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy Age 18 to 75 years old Estimated life expectancy of more than 3 months ECOG performance status of 2 or lower Adequate bone marrow function Adequate kidney function Adequate liver function No prior radiation therapy to more than 25 percent of BM Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study Women of childbearing potential must have a negative pregnancy test on admission The patient must be able to understand the study and has given written informed consent to participate in the study Exclusion Criteria: Other tumor types than adenocarcinoma Central nervous system metastases or prior radiation for CNS metastasis Gastric outlet obstruction or intestinal obstruction Evidence of active gastrointestinal bleeding Bony metastasis as the sole evaluable disease Past or concurrent history of neoplasm other than stomach cancer Pregnant or lactating women, women of childbearing potential not employing adequate contraception Thyroid disease
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00729482
Other Study ID Numbers ^ICMJE	AMC0702
Has Data Monitoring Committee	No
Responsible Party	Yoon-Koo Kang, Asan Medical Center
Study Sponsor ^ICMJE	Asan Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asan Medical Center
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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