Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00495872
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Dasatinib — DRUG
    50 mg by mouth (PO) Twice Daily for 28 Days Every 28 Days
  • Erlotinib — DRUG
    100 mg PO Daily for 28 Days Every 28 Days
  • Lapatinib — DRUG
    1000 mg PO Daily for 28 Days Every 28 Days
  • Lenalidomide — DRUG
    15 mg PO Daily for 28 Days Every 28 Days
  • Sorafenib — DRUG
    400 mg PO Daily for 21 Days Every 28 Days
  • Sunitinib — DRUG
    25 mg PO Daily for 21 Days Every 28 Days
  • Valproic Acid — DRUG
    40 mg/kg PO Daily for 7 Days, then 7 Days Off

Study Details

The goal of this clinical research study is to find the highest tolerable dose of valproic acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer. The safety of each combination of the study drugs will be studied as well.

Key Dates

Start date
Jun 30, 2007
Status verified
Oct 2012
Primary completion
Oct 31, 2012

Study Design

Enrollment
204 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VN
    Valproic Acid + Sorafenib
  • Experimental: VS
    Valproic Acid + Sunitinib
  • Experimental: VD
    Valproic Acid + Dasatinib
  • Experimental: VT
    Valproic Acid + Erlotinib
  • Experimental: VL
    Valproic Acid + Lapatinib
  • Experimental: VR
    Valproic Acid + Lenalidomide

Primary Outcome Measure

Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities [ Time Frame: At Day 28 (1 Cycle) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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