Viewing Study NCT01634893



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Last Modification Date: 2024-10-26 @ 10:53 AM
Study NCT ID: NCT01634893
Status: COMPLETED
Last Update Posted: 2016-03-25
First Post: 2012-07-03

Brief Title: Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Patients With Refractory or Relapsed Solid Tumors
Sponsor: The University of Texas Health Science Center at San Antonio
Organization: The University of Texas Health Science Center at San Antonio

Study Overview

Official Title: A Phase I Dose-Escalation Trial of Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Patients With Refractory or Relapsed Solid Tumors
Status: COMPLETED
Status Verified Date: 2016-03
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: None
Brief Summary: Patients with recurrent refractory or metastatic solid tumors have a dismal prognosis with few viable treatment options Hydroxychloroquine HCQ is an agent that has been widely used to treat malaria Because HCQ also inhibits autophagy a process central to survival of cancer in the face of metabolic stress including the effects of anti-cancer therapy it is now in human cancer trials combined with other agents to attempt to boost the efficacy of those agents Autophagy inhibition improves the activity of sorafenib in hepatocellular carcinoma

Sorafenib is an oral multi-kinase inhibitor that blocks not only receptor tyrosine kinases such as KIT VEGFR and PDGFR but also serinethreonine kinases along the RASRAFMEKERK pathway

The investigators propose to treat patients with refractory or relapsed solid tumors with sorafenib to boost its efficacy while attempting to mitigate its toxicity by combining with HCQ
Detailed Description: None

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
HSC20120203H OTHER UTHSCSA IRB None