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

NCT00495872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2012-10-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dasatinib

50 mg by mouth (PO) Twice Daily for 28 Days Every 28 Days

DRUG

Erlotinib

100 mg PO Daily for 28 Days Every 28 Days

DRUG

Lapatinib

1000 mg PO Daily for 28 Days Every 28 Days

DRUG

Lenalidomide

15 mg PO Daily for 28 Days Every 28 Days

DRUG

Sorafenib

400 mg PO Daily for 21 Days Every 28 Days

DRUG

Sunitinib

25 mg PO Daily for 21 Days Every 28 Days

DRUG

Valproic Acid

40 mg/kg PO Daily for 7 Days, then 7 Days Off

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Aung Naing, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00495872 on ClinicalTrials.gov