RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00729482
First received: August 4, 2008
Last updated: December 31, 2013
Last verified: December 2013

August 4, 2008
December 31, 2013
July 2008
September 2011   (final data collection date for primary outcome measure)
Progression-free Survival Rate at 4-month (16 Weeks) [ Time Frame: 4 months (16 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729482 on ClinicalTrials.gov Archive Site
  • Response Rate [ Time Frame: 2years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Toxicity Profiles (According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • response rate [ Time Frame: no time frame (best response) ] [ Designated as safety issue: No ]
  • overall survival [ Designated as safety issue: No ]
  • toxicities [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer

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%.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasm
Drug: RAD001
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Other Name: everolimus
Experimental: 1
Treatment Arm (RAD001)
Intervention: Drug: RAD001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
March 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00729482
AMC-ONCGI-0801
No
Yoon-Koo Kang, Asan Medical Center
Asan Medical Center
Not Provided
Not Provided
Asan Medical Center
December 2013

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