Reccurent/Metastatic Solid Tumor Disease Clinical Trial
Official title:
A Randomized Proof-of-concept Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment