RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX

Phase 1

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: RAD001, Capecitabine, Oxaliplatin

• Registration Number: NCT01049620
• Lead Sponsor: Asan Medical Center

Brief Summary

It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in combination with conventional chemotherapy. In this study, XELOX was selected as a conventional combination chemotherapy because it was proven very active and safe in gastric cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer patients yet. So, the optimal dose will be first determined in this phase I study

Detailed Description

For the first cohort of this phase I study, each drug of capecitabine, oxaliplatin, and RAD001 will be started at one or two dose below the ordinary full dose of each drug as a single agent.

Study Timeline

• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Study Start: 2010-02
• Primary Completion: 2011-07
• Study Completion: 2013-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction
• No history of chemotherapy or radiation
• Age 18 to 70 years old
• Estimated life expectancy of at least 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate bone marrow function (white blood cell counts >3,000/uL, absolute neutrophil count>1,500/uL, Platelets>100,000/uL, Hgb>8 g/dL)
• Adequate kidney function (creatinine<1.5 mg/dL)
• Adequate liver function (bilirubin<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <3 times the upper normal limit (5 times for patients with liver metastasis))
• Signed written informed consent

Exclusion Criteria

• Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
• Presence of central nervous system metastasis
• Bowel obstruction
• Evidence of serious gastrointestinal bleeding
• Peripheral neuropathy (NCI CTC AE version 3.0 > Grade I)
• History of significant neurologic or psychiatric disorders
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• Other serious illness or medical conditions
• Patients with known history of ischemic heart disease and/or with myocardial infarction
• Known allergy to study drugs
• Administration of drugs showing interaction with RAD001

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Xelox+RAD001	RAD001, Capecitabine, Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
To assess the maximum tolerated dose (MTD)	1year

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	2 years
Overall survival	1 year
Biomarker study	1 year
Response rate	2 years

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of