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Study 7 of 420 for search of: | received on or after 12/30/2008 |
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Sponsored by: |
Immune Control |
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Information provided by: | Immune Control |
ClinicalTrials.gov Identifier: | NCT00821301 |
The purpose of this study is to evaluate the safety and tolerability of fluphenazine in patients with advanced multiple myeloma. The study will also describe the efficacy of this drug.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Fluphenazine HCl |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase 1b Single Arm, Open Label, Multi-Center Study of Fluphenazine HCl Monotherapy in Relapsed or Relapsed-and-Refractory Multiple Myeloma |
Estimated Enrollment: | 30 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
This is a multicenter, dose-escalating, Phase 1b trial in patients with relapsed or relapsed-and-refractory multiple myeloma. Patients will be dosed on Days 1 and 8 of each 21 day cycle.
This study will be conducted in two parts. In Part 1, the MTD determining portion of the study, patients will be enrolled in cohorts of 3 patients at each dose level. At least 3 patients will complete 21 days at each dose level and will be evaluated for safety and tolerability before additional patients are treated at higher doses. Doses will be increased following a modified Fibonacci scheme.
In Part 2, twelve additional patients will be enrolled at the MTD determined in Part 1 (or the dose for the highest dose cohort completed if the MTD has not been reached) to further evaluate the safety, tolerability, and preliminary efficacy of this dose regimen.
Serum fluphenazine pharmacokinetic studies will be performed during the first cycle of the therapy in all Part 1 and Part 2 consenting patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephen Roth, Ph.D. | 610-941-2972 | sroth@immunecontrol.com |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Kristine Mykulowycz, RN 215-898-1972 kristine.mykulowycz@uphs.upenn.edu | |
Contact: Ed Stadtmauer, MD 215-614-0910 edward.stadtmauer@uphs.upenn.edu | |
Principal Investigator: Ed Stadtmauer, MD | |
University of Pittsburgh Cancer Institute Hillman Cancer Center | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Amy O'Sullivan 412-623-4882 osullivanal@upmc.edu | |
Contact: Suzanne Lentzsch, MD 412-648-6586 lentzschs@upmc.edu | |
Principal Investigator: Suzanne Lentzsch, MD | |
United States, Texas | |
Cancer Therapy and Research Center at the UT Health Sciences Center at San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Lyanna Smith, BSN, RN 210-450-5816 smithl6@uthscsa.edu | |
Contact: Swaminathan Padmanabhan, MD 210-450-5882 PadmanabhanS@uthscsa.edu | |
Principal Investigator: Swaminathan Padmanabhan, MD |
Study Director: | Bruce A Silver, M.D., FACP | Unaffiliated |
Responsible Party: | Immune Control Inc. ( Stephen Roth, Ph.D. ) |
Study ID Numbers: | FM-CL2 |
Study First Received: | January 9, 2009 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00821301 |
Health Authority: | United States: Food and Drug Administration; India: Drugs Controller General of India |
Multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Benzocaine Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Dopamine Hemorrhagic Disorders Multiple myeloma Fluphenazine depot Lymphoproliferative Disorders Fluphenazine Neoplasms, Plasma Cell |
Neurotransmitter Agents Neoplasms by Histologic Type Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Neoplasms Therapeutic Uses Dopamine Agents Cardiovascular Diseases Central Nervous System Agents |