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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 : February 13, 2014
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

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%.

Condition or disease Intervention/treatment Phase
Stomach Neoplasm Drug: RAD001 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer
Study Start Date : July 2008
Primary Completion Date : September 2011
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Treatment Arm (RAD001)
Drug: RAD001
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Other Name: everolimus

Primary Outcome Measures :
  1. Progression-free Survival Rate at 4-month (16 Weeks) [ Time Frame: 4 months (16 weeks) ]

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 2years ]
  2. Overall Survival [ Time Frame: 1 year ]
  3. Toxicity Profiles (According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0) [ Time Frame: up to 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Asan Medical Center

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00729482     History of Changes
Other Study ID Numbers: AMC-ONCGI-0801
First Posted: August 7, 2008    Key Record Dates
Results First Posted: February 13, 2014
Last Update Posted: February 13, 2014
Last Verified: December 2013

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
RAD001 (everolimus)
second-line treatment
advanced gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents