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Hydroxychloroquine + Vorinostat in Advanced Solid Tumors

NCT01023737 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-02-13

No results posted yet for this study

Summary

This study is an open label non randomized study of hydroxychloroquine (HCQ) with histone deacetylase (HDAC) inhibitor Vorinostat in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) and to evaluate the safety and antitumor activity of this drug combination.

Conditions

  • Malignant Solid Tumour

Interventions

DRUG

Hydroxychloroquine

The HCQ study dose levels are defined as 400mg/day, 600mg/day, 800mg/day and 1000mg/day (oral dosing)during the phase I MTD determination. HCQ will be administered starting on Day 2 of Cycle 1 and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.

DRUG

Vorinostat

Oral administration of Vorinostat will be begin on Cycle 1 Day 1 at 300mg and will be continued daily thereafter until progression of disease or unacceptable toxicity develops.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Sukeshi Patel Arora, MD · University of Texas Health Science Center San Antonio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2017-12-05
Completion
2023-01-08

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01023737 on ClinicalTrials.gov