A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapy

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

- Histologically or cytologically confirmed and documented gastric adenocarcinoma.
- Progression after 1 or 2 prior systemic chemotherapy treatments for advanced disease. Prior adjuvant/neoadjuvant therapy is allowed.
- ECOG performance status of * 2
- Patients with the following laboratory parameters:
* Absolute neutrophil count * 1.5 x 109/L
* Platelets * 100 x 109/L
* Hemoglobin (Hgb) * 4.9 mmol/L
* INR * 2.0
* Serum creatinine * 2 x Upper Limit of Normal (ULN)
* Adequate liver function (no evidence of liver metastasis: ALT and AST * 2.5 x ULN and with liver metastases: ALT and AST * 5.0 x ULN)
* Serum bilirubin * 1.5 ULN (Upper Limit of Normal)
* Normal serum calcium and serum potassium

Exclusion Criteria

- Patients who have received > 2 prior systemic therapies for advanced disease. Note: If recurrence occurred during or * 24 weeks after adjuvant/neoadjuvant therapy the adjuvant/neoadjuvant therapy will be considered as one prior regimen of systemic chemotherapy.
- Administration of anti-cancer therapy within 3 weeks prior to randomization
- Known hypersensitivity to RAD001 (everolimus) or to other rapamycins
- Chronic treatment with steroids
- Major surgery * 2 weeks prior to randomization
- Malignant ascites requiring invasive therapy
- Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, radiotherapy, or surgical procedure CTC grade * 1 except neuropathy with grade 2 or less and alopecia.
- Central nervous system metastases
- Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid (as long asINR is * 2.0)
- Any malignancy within 3 years of randomization (except in situ carcinoma of cervix, basal or squamous cell carcinoma)
- Any severe and/or uncontrolled medical conditions such as:
* Unstable cardiac disease
* Uncontrolled diabetes
* Acute and chronic, uncontrolled active infectious disorders and nonmalignant medical illnesses
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs, with the exception of prior gastrectomy (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).
Note: Data from the phase II Japanese study of RAD001 in AGC does not show that gastrectomy impairs the absorption of RAD001.
* Active skin, mucosa, ocular or GI disorders of Grade > 1
* Chronic obstructive or restrictive pulmonary disease including dyspnea at rest from any cause
- Patients who are enterally fed

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is overall survival (OS), defined as the<br /><br>time from date of randomization to date of death due to any cause. If death has<br /><br>not been observed at the date of the analysis cutoff then OS will be censored<br /><br>at the date of the last contact.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary efficacy objectives were to compare RAD001 against placebo with<br /><br>respect to progression-free survival (PFS), quality of life, and time to<br /><br>definitive deterioration in the ECOG PS scale.<br /><br>A hierarchical testing strategy will be adopted in this study. PFS will be<br /><br>compared between the two treatment arms provided the primary endpoint </p><br>

Related Trials

Study with a chemotherapy of paclitaxel with or without RAD001 in patients with gastric cancer after progressio

Phase 1

Krankenhaus Nordwest GmbH

Updated 6/22/2020