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

NCT00729482 | Completed Phase 2 Results

• 1 other identifier: AMC0801
• Study Type: interventional
• Target: 54
• 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, 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%.

Conditions

Stomach Neoplasm

Keywords

RAD001 (everolimus); second-line treatment; advanced gastric cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate at 4-month (16 Weeks)

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

  4 months (16 weeks)

Secondary Outcomes (3)

• Response Rate

  2years

• Overall Survival

  1 year

• Number of Participants With Adverse Events

  up to 24 weeks

Study Arms (1)

1

EXPERIMENTAL

Treatment Arm (RAD001)

Drug: RAD001

Interventions

RAD001 DRUG

RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability

Also known as: everolimus

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa, 138-736, 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

Results Point of Contact

• Title: Dr. Yoon-Koo Kang
• Organization: Asan Medical Center

ykkang@amc.seoul.kr

+82-2-3010-3210

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 4, 2008
• First Posted: August 7, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2013
• Last Updated: January 7, 2020
• Results First Posted: February 13, 2014

Record last verified: 2020-01

Locations

KR (1)