NCT01771458

A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer

A Randomized Proof-of-concept Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 742 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies for patients with refractory cancer. From a tumor biopsy, a molecular profile of the disease is established (mutations, amplifications, hormone receptor status). If a molecular abnormality is identified for which an approved targeted agent is available, patients are randomized randomized between two arms: * Targeted therapy based on the molecular profile * Conventional therapy based on investigator's choice. A cross-over is proposed at disease progression.

Conditions

• Reccurent/Metastatic Solid Tumor Disease

Interventions

Type	Name	Description
DRUG	Targeted therapy based on molecular profiling : Imatinib
PROCEDURE	Tumor biopsy
DRUG	Standard Chemotherapy
DRUG	Targeted therapy based on molecular profiling : Everolimus
DRUG	Targeted therapy based on molecular profiling : Vemurafenib
DRUG	Targeted therapy based on molecular profiling : Sorafenib
DRUG	Targeted therapy based on molecular profiling : Erlotinib
DRUG	Targeted therapy based on molecular profiling : Lapatinib + Trastuzumab
DRUG	Targeted therapy based on molecular profiling : Dasatinib
DRUG	Targeted therapy based on molecular profiling : Tamoxifen (or letrozole if contra-indication)
DRUG	Targeted therapy based on molecular profiling : Abiraterone

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2013-01-18
• Last updated: 2025-11-24

Locations

8 sites across 1 country: France