Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

Novartis

Status and phase: Completed; Phase 2

Conditions: Gastro-esophageal Junction Cancer; Advanced Gastric Cancer

Treatments: Drug: Irinotecan; Drug: AUY922; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084330

2009-015407-47 (EudraCT Number)

CAUY922A2202

Details and patient eligibility

About

A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Radiologically confirmed advanced gastric cancer
• One previous line of chemotherapy
• Progressive disease
• One measurable lesion
• Blood tests within protocol ranges
• (WHO) Performance Status ≤ 1
• Able to sign informed consent

Exclusion criteria

• No symptomatic brain metastases
• No coumarin type anticoagulants
• No liver or kidney disease
• No impaired heart function
• No pregnant or lactating women

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

AUY922

Experimental group

Treatment:

Drug: AUY922

Docetaxel or Irinotecan

Active Comparator group

Treatment:

Drug: Irinotecan

Drug: Docetaxel