Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) (GRANITE-1)

Novartis

Status and phase: Completed; Phase 3

Conditions: Advanced Gastric Cancer

Treatments: Drug: Everolimus placebo; Drug: Everolimus; Drug: Best Supportive Care (BSC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00879333

2008-006544-20 (EudraCT Number)

CRAD001R2301

Details and patient eligibility

About

This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

Enrollment: 656 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients > 18 years old
• Histologically or cytologically confirmed and documented gastric adenocarcinoma
• Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease
• ECOG Performance Status of < 2
• Lab parameters within specifically defined intervals
• Able to provide written informed consent

Exclusion criteria

• Patients who have received > 2 prior systemic therapies for advanced disease
• Administration of another anticancer therapy within 3 weeks prior to randomization
• Chronic treatment with steroids or another immunosuppressive agent
• Major surgery within 2 weeks prior to randomization
• Patients with CNS metastases
• Any other severe and/or uncontrolled medical condition

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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656 participants in 2 patient groups, including a placebo group

Everolimus + BSC

Experimental group

Description:

All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.

Treatment:

Drug: Best Supportive Care (BSC)

Drug: Everolimus

Placebo + BSC

Placebo Comparator group

Description:

All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.

Treatment:

Drug: Best Supportive Care (BSC)

Drug: Everolimus placebo