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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00495872 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
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Solid Tumors |
Drug: Dasatinib Drug: Erlotinib Drug: Lapatinib Drug: Lenalidomide Drug: Sorafenib Drug: Sunitinib Drug: Valproic Acid |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Arm Complete Phase 1 Trial of Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor |
Estimated Enrollment: | 192 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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VN: Experimental
Valproic Acid + Sorafenib
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Drug: Sorafenib
400 mg PO Daily for 21 Days Every 28 Days
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
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VS: Experimental
Valproic Acid + Sunitinib
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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
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VD: Experimental
Valproic Acid + Dasatinib
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Drug: Dasatinib
50 mg PO Twice Daily for 28 Days Every 28 Days
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
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VT: Experimental
Valproic Acid + Erlotinib
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Drug: Erlotinib
100 mg PO Daily for 28 Days Every 28 Days
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
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VL: Experimental
Valproic Acid + Lapatinib
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Drug: Lapatinib
1000 mg PO Daily for 28 Days Every 28 Days
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
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VR: Experimental
Valproic Acid + Lenalidomide
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Drug: Lenalidomide
15 mg PO Daily for 28 Days Every 28 Days
Drug: Valproic Acid
40 mg/kg PO Daily for 7 Days, then 7 Days Off
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aung Aung, MD | 713-563-0181 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Aung Naing, MD |
Principal Investigator: | Aung Naing, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Aung Naing PhD/Assistant Professor ) |
Study ID Numbers: | 2007-0170 |
Study First Received: | July 2, 2007 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00495872 History of Changes |
Health Authority: | United States: Institutional Review Board |
Solid Tumors Advanced Cancer Dasatinib Erlotinib Lapatinib Lenalidomide |
Sorafenib Erlotinib Hydrochloride Sunitinib Malate Sunitinib Valproic Acid SU011248 |
Erlotinib Neurotransmitter Agents Tranquilizing Agents Lenalidomide Psychotropic Drugs Central Nervous System Depressants Lapatinib Antimanic Agents |
Angiogenesis Inhibitors Protein Kinase Inhibitors Valproic Acid Sunitinib Dasatinib Sorafenib Anticonvulsants |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Valproic Acid Protein Kinase Inhibitors Sunitinib Dasatinib Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Erlotinib |
Tranquilizing Agents Growth Substances Lenalidomide Central Nervous System Depressants Lapatinib Enzyme Inhibitors Antimanic Agents Angiogenesis Inhibitors Pharmacologic Actions GABA Agents Central Nervous System Agents Sorafenib Anticonvulsants |