Trial Outcomes & Findings for RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment (NCT NCT00729482)

NCT ID: NCT00729482

Last Updated: 2020-01-07

Results Overview

progression is definced as a more than 20% increase in one or more lesions or the appearance of any new lesion

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: 4 months (16 weeks)
• Results posted on: 2020-01-07

Participant Flow

Participant milestones

Measure	RAD001 Treatment Arm (RAD001) take RAD001 10mg/day dose (two 5mg tablets) orally evert day with a glass of water at the same time each day in a fasting state or with a light fat-free meal.
Overall Study STARTED	54
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	RAD001 n=54 Participants Treatment Arm (RAD001)
Age, Customized	57.5 years n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	45 Participants n=93 Participants
Region of Enrollment Korea, Republic of	54 participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	RAD001 n=54 Participants Treatment Arm (RAD001)
Progression-free Survival Rate at 4-month (16 Weeks)	18.4 percentage of participants

SECONDARY outcome

Timeframe: 2years

Population: 51 patients were available for response assessments.

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.

Outcome measures

Measure	RAD001 n=51 Participants Treatment Arm (RAD001)
Response Rate	3.7 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	RAD001 n=54 Participants Treatment Arm (RAD001)
Overall Survival	8.3 Months Interval 4.5 to 12.1

SECONDARY outcome

Timeframe: up to 24 weeks

(according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0)

Outcome measures

Measure	RAD001 n=54 Participants Treatment Arm (RAD001)
Number of Participants With Adverse Events	54 participants

Adverse Events

RAD001

Serious events: 5 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	RAD001 n=54 participants at risk Treatment Arm (RAD001)
Gastrointestinal disorders Ileus	1.9% 1/54 • At least 6 months after last dose of chemotherapy.
Infections and infestations Pneumonia	5.6% 3/54 • At least 6 months after last dose of chemotherapy.
Cardiac disorders Sudden death	1.9% 1/54 • At least 6 months after last dose of chemotherapy.
Gastrointestinal disorders Gastrointestinal bleeding	1.9% 1/54 • At least 6 months after last dose of chemotherapy.

Other adverse events

Measure	RAD001 n=54 participants at risk Treatment Arm (RAD001)
Blood and lymphatic system disorders Neutropenia	42.6% 23/54 • At least 6 months after last dose of chemotherapy.
Blood and lymphatic system disorders Anemia	94.4% 51/54 • At least 6 months after last dose of chemotherapy.
Blood and lymphatic system disorders Thrombocytopenia	87.0% 47/54 • At least 6 months after last dose of chemotherapy.
Metabolism and nutrition disorders Hypercholesterolemia	44.4% 24/54 • At least 6 months after last dose of chemotherapy.
Metabolism and nutrition disorders Triacylglyceridemia	24.1% 13/54 • At least 6 months after last dose of chemotherapy.
Metabolism and nutrition disorders Hyperglycemia	87.0% 47/54 • At least 6 months after last dose of chemotherapy.
Hepatobiliary disorders Hyperbilirubinemia	25.9% 14/54 • At least 6 months after last dose of chemotherapy.
Hepatobiliary disorders Elevated alkaline phosphatase	33.3% 18/54 • At least 6 months after last dose of chemotherapy.
Hepatobiliary disorders Elevated aspartate aminotransferase	59.3% 32/54 • At least 6 months after last dose of chemotherapy.
Hepatobiliary disorders Elevated alanine aminotransferase	37.0% 20/54 • At least 6 months after last dose of chemotherapy.
Hepatobiliary disorders Elevated gamma glutamyl transpeptidase	31.5% 17/54 • At least 6 months after last dose of chemotherapy.
Metabolism and nutrition disorders Hypophosphatemia	25.9% 14/54 • At least 6 months after last dose of chemotherapy.
Renal and urinary disorders Hyponatremia	44.4% 24/54 • At least 6 months after last dose of chemotherapy.
General disorders Asthenia	96.3% 52/54 • At least 6 months after last dose of chemotherapy.
Musculoskeletal and connective tissue disorders Myalgia	37.0% 20/54 • At least 6 months after last dose of chemotherapy.
Gastrointestinal disorders Diarrhea	35.2% 19/54 • At least 6 months after last dose of chemotherapy.
Gastrointestinal disorders Constipation	27.8% 15/54 • At least 6 months after last dose of chemotherapy.
Gastrointestinal disorders Anorexia	79.6% 43/54 • At least 6 months after last dose of chemotherapy.
Gastrointestinal disorders Nausea	38.9% 21/54 • At least 6 months after last dose of chemotherapy.
Gastrointestinal disorders Stomatitis	75.9% 41/54 • At least 6 months after last dose of chemotherapy.
Skin and subcutaneous tissue disorders Skin rash	64.8% 35/54 • At least 6 months after last dose of chemotherapy.
Skin and subcutaneous tissue disorders Hand-foot syndrome	24.1% 13/54 • At least 6 months after last dose of chemotherapy.
Blood and lymphatic system disorders Hemorrhage	33.3% 18/54 • At least 6 months after last dose of chemotherapy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	14.8% 8/54 • At least 6 months after last dose of chemotherapy.

Additional Information

Dr. Yoon-Koo Kang

Asan Medical Center

Phone: +82-2-3010-3210

Email: ykkang@amc.seoul.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place