Status:
COMPLETED
RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression
Lead Sponsor:
Asan Medical Center
Conditions:
Stomach Neoplasm
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
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, overall survival and biomarker assessment (...
Detailed Description
Methodology: Prospective, non blinded, open label, single center phase II study Criteria for evaluation: Assessment of response will be assessed radiologically according to RECIST criteria after comp...
Eligibility Criteria
Inclusion
- histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
- non-resectable disease by metastasis or recurrent disease after curative surgical resection (See Appendix A) with uni-dimensionally measurable disease
- failure of 1st line chemotherapy including fluoropyrimidine (capecitabine, S1, or 5-FU,) and platinum (cisplatin or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
- High expression of pS6 Ser 240/4 (proportion of pS6 Ser 240/4 positive cancer cells by immunohistochemistry \> 10%)
- Age 20 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
- Fasting serum cholesterol ≤ 300 mg/dL AND fasting triglyceride ≤ 2.5 X ULN
- No prior radiation therapy to more than 25% of BM
- 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
- Written informed consent
Exclusion
- Other tumor type than adenocarcinoma
- CNS metastases or prior radiation for CNS metastases
- Gastric outlet obstruction or intestinal obstruction
- Evidence of active gastrointestinal bleeding
- Bone lesions 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
- Other serious illness or medical conditions
- Concomitant or with a 4-week period administration of any other experimental drug under investigation
- Concomitant chemotherapy, hormonal therapy, or immunotherapy
- Any preexisting medical condition of sufficient severity to prevent full compliance with the study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01482299
Start Date
November 1 2011
End Date
January 1 2014
Last Update
January 7 2020
Active Locations (1)
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1
Asan Medical Center
Songpa-gu, Seoul, South Korea