RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression

NCT01482299 | Completed Phase 2

• 1 other identifier: AMC1104
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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, overall survival and biomarker assessment (secondary end-points) in patients with metastatic or recurrent gastric cancer with pS6 Ser 240/4 expression. Eligibility criteria include pathologically proven non-resectable adenocarcinoma of stomach with measurable disease who failed previous first-line palliative chemotherapy including fluoropyrimidine and platinum with high expression of pS6 Ser 240/4. 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. A study requires 40 assessable subjects to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less than or equal to 0.1 or greater than or equal to 0.25 with a target error rate of 0.05 and β of 0.2. If the number of responses is 7 or less, the hypothesis that P \>= 0.250 is rejected with a target error rate of 0.200 and an actual error rate of 0.182. If the investigators assume that drop-out rate is 10%, total accrual patient will be 45.

Conditions

Stomach Neoplasm

Keywords

pS6 Ser 240/4; RAD001 (everolimus); second-line treatment; advanced gastric cancer

Outcome Measures

Primary Outcomes (1)

• 4-month progression-free survival

  Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.

  up to 3years

Secondary Outcomes (4)

• Response rate

  Up to 1year

• Number of participants with adverse events

  Monitoring of adverse events will be contineud for at least 28days following the last dose of study treatment

• Overall survival

  Up to 3years

• Biomarker assessment

  24months

Study Arms (1)

RAD001 (everolimus)

EXPERIMENTAL

Drug: RAD001

Interventions

RAD001 DRUG

RAD001 (everolimus) 10 mg daily, orally without interruption. 1 cycle is equal to 4-week treatment. Treatment will be continued unless disease progression or intolerability.

Also known as: everolimus

RAD001 (everolimus)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
• non-resectable disease by metastasis or recurrent disease after curative surgical resection (See Appendix A) with uni-dimensionally measurable disease
• failure of 1st line chemotherapy including fluoropyrimidine (capecitabine, S1, or 5-FU,) and platinum (cisplatin or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
• High expression of pS6 Ser 240/4 (proportion of pS6 Ser 240/4 positive cancer cells by immunohistochemistry \> 10%)
• Age 20 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
• Fasting serum cholesterol ≤ 300 mg/dL AND fasting triglyceride ≤ 2.5 X ULN
• No prior radiation therapy to more than 25% of BM
• 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
• Written informed consent

You may not qualify if:

• Other tumor type than adenocarcinoma
• CNS metastases or prior radiation for CNS metastases
• Gastric outlet obstruction or intestinal obstruction
• Evidence of active gastrointestinal bleeding
• Bone lesions 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
• Other serious illness or medical conditions
• Concomitant or with a 4-week period administration of any other experimental drug under investigation
• Concomitant chemotherapy, hormonal therapy, or immunotherapy
• Any preexisting medical condition of sufficient severity to prevent full compliance with the study

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Songpa-gu, Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Yoon-Koo Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 30, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

KR (1)