Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT02316340
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    400mg by mouth daily
  • Hydroxychloroquine — DRUG
    600mg by mouth daily
  • Regorafenib — DRUG
    160 mg by mouth daily

Study Details

This will be a randomized phase II clinical trial of patients with histologic documentation of metastatic colorectal cancer, who have received local and currently approved standard therapies, excluding RGF.

Key Dates

Start date
Feb 11, 2015
Status verified
Jan 2024
Primary completion
Mar 7, 2018
Completion
Apr 16, 2018

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm - VOR with HCQ
    Patients will be given vorinostat 400 mg daily and hydroxychloroquine 600 mg daily in 4 week cycles.
  • Active Comparator: Control Arm - Regorafenib
    Patients will be given oral RGF 160 mg daily for 3 weeks in 4 week cycles.

Primary Outcome Measure

Efficacy Based on Progression Free Survival of Vorinostat and Hydroxychloroquine Compared to Regorafenib [ Time Frame: Baseline to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Therapy and Research Center University of Texas Health Science Center San AntonioSan AntonioTexas78229-

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