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NCT01634893 · ClinicalTrials.gov registry record · Phase 1

Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Patients With Refractory or Relapsed Solid Tumors

A Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT01634893 is a Phase 1 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 18 participants.

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The verdict

NCT01634893, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study 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 serine/threonine kinases along the RAS/RAF/MEK/ERK 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.

Interventions

  • DRUG Sorafenib combined with Hydroxychloroquine

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2012-06
Est. Completion 2015-12
Phase Phase 1

What the Registry Record Tells You About NCT01634893

The ClinicalTrials.gov registry entry for NCT01634893 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Sorafenib combined with Hydroxychloroquine is the first listed.

NCT01634893 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01634893 about?

NCT01634893 is a clinical study titled "Oral Hydroxychloroquine Plus Oral Sorafenib to Treat Patients With Refractory or Relapsed Solid Tumors". 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 metab...

What is the current status of trial NCT01634893?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-06. Estimated completion is 2015-12.

What interventions are being tested in trial NCT01634893?

The interventions under investigation include: Sorafenib combined with Hydroxychloroquine (DRUG).

Who is sponsoring clinical trial NCT01634893?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.