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Sponsored by: |
Cylene Pharmaceuticals |
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Information provided by: | Cylene Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00891280 |
This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability and highest safe dose level of this CK2 inhibitor in patients with advanced solid tumor cancers, Castleman's Disease or Multiple Myeloma.
Condition | Intervention | Phase |
---|---|---|
Advanced Solid Tumors Breast Cancer Inflammatory Breast Cancer Castleman's Disease Multiple Myeloma |
Drug: CX-4945 oral formulation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Advanced Solid Tumors, Castleman's Disease or Multiple Myeloma |
Estimated Enrollment: | 40 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth and overexpression of CK2 has been documented in multiple types of cancer. CK2 has emerged as a potential anticancer target and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic (PD) effects of CX-4945 administered to patients with malignancies or lymphoproliferative disorders known to overexpress CK2 including advanced solid tumors, Multiple Myeloma and Castleman's Disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically or cytologically confirmed malignancy or lymphoproliferative disorder known to over express CK2 which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available, including the following types: (examples)
Exclusion Criteria:
United States, Arizona | |
Mayo Clinic Arizona | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
Contact: Clinical Trials Office Mayo Clinic Cancer Center 507-538-7623 | |
Principal Investigator: Donald Northfelt, MD | |
United States, Colorado | |
Front Range Cancer Specialists | Recruiting |
Fort Collins, Colorado, United States, 80528 | |
Contact: J. Shelby, RN 970-212-7609 | |
Principal Investigator: Robert F Marschke, MD |
Study Director: | Study Director | Cylene Pharmaceuticals |
Responsible Party: | Cylene Pharmaceuticals Inc ( Study Director ) |
Study ID Numbers: | C4-08-001 |
Study First Received: | April 29, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00891280 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Inflammatory breast cancer Castleman's Disease Multiple Myeloma |
Breast cancer Solid tumors CK2 inhibitor |
Immunoproliferative Disorders Skin Diseases Hematologic Diseases Blood Protein Disorders Giant Lymph Node Hyperplasia Blood Coagulation Disorders Vascular Diseases Breast Neoplasms Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphatic Diseases Hyperplasia Hemorrhagic Disorders Inflammatory Breast Cancer Castleman's Disease Lymphoproliferative Disorders Breast Diseases Neoplasms, Plasma Cell |
Immunoproliferative Disorders Neoplasms by Histologic Type Skin Diseases Immune System Diseases Hematologic Diseases Blood Protein Disorders Giant Lymph Node Hyperplasia Vascular Diseases Breast Neoplasms Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Lymphatic Diseases Neoplasms Hemorrhagic Disorders Neoplasms by Site Cardiovascular Diseases Lymphoproliferative Disorders Breast Diseases Neoplasms, Plasma Cell |