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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: Completed Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the toxicities of combining sorafenib plus HCQ in this patient population
Interventions
- DRUG Sorafenib combined with Hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01634893 record still lists
NCT01634893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Sorafenib combined with Hydroxychloroquine is the first listed.
NCT01634893 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01634893's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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