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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 : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE August 4, 2008
First Posted Date  ICMJE August 7, 2008
Results First Submitted Date  ICMJE December 31, 2013
Results First Posted Date  ICMJE February 13, 2014
Last Update Posted Date November 27, 2018
Study Start Date  ICMJE July 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
Progression-free Survival Rate at 4-month (16 Weeks) [ Time Frame: 4 months (16 weeks) ]
progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2008)
Progression-free Survival Rate at 4-month (16 Weeks) [ Time Frame: 4 months (16 weeks) ]
Change History Complete list of historical versions of study NCT00729482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • Response Rate [ Time Frame: 2years ]
    Tumor response is evaluated according to the new guidelines by RECIST criteria (See Appendix D). A complete response (CR) is defined as the disappearance of all evidence of cancer for 4 weeks or longer. A partial response (PR) is defined as a 30% or more reduction in the sum of the longest diameters of target lesions for 4 weeks or longer without any evidence of new lesions or progression of any lesions. Stable disease is defined as less than a 30% reduction or less than a 20% increase in the longest diameters of target lesions without any evidence of new lesions. Progressive disease is defined as a more than 20% increase in one or more lesions or the appearance of any new lesion.
  • Overall Survival [ Time Frame: 1 year ]
  • Number of Participants With Adverse Events [ Time Frame: up to 24 weeks ]
    (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2008)
  • Response Rate [ Time Frame: no time frame (best response) ]
  • Overall Survival
  • toxicities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: August 4, 2008)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729482
Other Study ID Numbers  ICMJE AMC-ONCGI-0801
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yoon-Koo Kang, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asan Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP