RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer: RAD001+XELOX
![]() |
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: NCT01049620 |
Recruitment Status :
Completed
First Posted : January 14, 2010
Last Update Posted : January 7, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Gastric Cancer | Drug: RAD001, Capecitabine, Oxaliplatin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Dose Finding Study of RAD001 in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Xelox+RAD001 |
Drug: RAD001, Capecitabine, Oxaliplatin
Dose level -1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 5mg po qd D1-21 Dose level 1 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 2 : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 3 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 3A : Capecitabine 800mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21 Dose level 3B : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 100mg/m2 iv D1 RAD001 10mg po qd D1-21 Dose level 4 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 7.5mg po qd D1-21 Dose level 5 : Capecitabine 1000mg/m2 po bid D1-14, Oxaliplatin 130mg/m2 iv D1 RAD001 10mg po qd D1-21 |
- To assess the maximum tolerated dose (MTD) [ Time Frame: 1year ]
- Progression-free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 1 year ]
- Biomarker study [ Time Frame: 1 year ]
- Response rate [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01049620
Korea, Republic of | |
Asan Medical Center, University of Ulsan College of Medicine | |
Seoul, Korea, Republic of, 138-736 |
Principal Investigator: | Yoon-Koo Kang, MD, PhD | Asan Medical Center |
Responsible Party: | Yoon-Koo Kang, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01049620 |
Other Study ID Numbers: |
AMC0905 |
First Posted: | January 14, 2010 Key Record Dates |
Last Update Posted: | January 7, 2020 |
Last Verified: | January 2020 |
XELOX RAD001 phase 1 |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Capecitabine |
Oxaliplatin Everolimus Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |