Study of Curcumin, Vorinostat, and Sorafenib

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01608139
Phase
PHASE1
Status
Withdrawn

Conditions

  • Advanced Cancers

Eligibility Criteria

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

Interventions

  • Curcumin — DRUG
    Starting dose: 4 grams by mouth per day. During the first cycle only, Curcumin given on Day 1. Beginning with Cycle 1 Day 5, all agents will be administered continuously.
  • Sorafenib — DRUG
    Starting dose: 200 mg by mouth daily. During the first cycle only, Sorafenib given on Day 5. Beginning with Cycle 1 Day 5, all agents will be administered continuously.
  • Vorinostat — DRUG
    Starting dose: 100 mg by mouth daily. During the first cycle only, Vorinostat given on Day 3. Beginning with Cycle 1 Day 5, all agents will be administered continuously.

Study Details

The goal of this clinical research study is to learn the highest tolerable dose of the combination of curcumin, vorinostat, and sorafenib that can be given to patients with advanced solid cancer. The safety of this drug combination will also be studied.

Key Dates

Start date
Nov 30, 2012
Status verified
Oct 2012
Primary completion
Nov 30, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Curcumin + Sorafenib + Vorinostat
    Participant assigned to a dose level of the study drug combination based on when joined this study. Up to 9 dose levels of the study drug combination will be tested. Three (3) to 6 participants will be enrolled at each dose level of the study drug combination. During first cycle only, Curcumin initiated on Day 1, Vorinostat on Day 3 and Sorafenib on Day 5. Beginning with Cycle 1 Day 5, all agents administered continuously. Cycle of therapy is 28 days. Starting dose of Curcumin: 4 grams by mouth per day on Day 1. Starting dose of Sorafenib: 200 mg by mouth daily beginning on Day 5. Starting dose of Vorinostat: 100 mg by mouth daily beginning on Day 3.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks ]

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