Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-28 @ 10:20 AM
Study NCT ID:
NCT01771458
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2012-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer
Sponsor:
Institut Curie
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIVA
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: