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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00710528 |
Purpose
The purpose of this study is to determine the dose that can be safely given to see what effect it may have on your cancer and to determine how the drug is distributed in the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia (CLL) Lymphoma, Non-Hodgkin (NHL) Acute Myeloid Leukemia (AML) Multiple Myeloma (MM) |
Drug: CAL-101 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients With Select, Relapsed or Refractory Hematologic Malignancies |
| Enrollment: | 192 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: one arm |
Drug: CAL-101
CAL-101 50, 100, 150, 200, 350 mg capsules BID for 28 days CAL-101 150, 300 mg QD for 28 days CAL-101 150 mg BID 3 weeks on 1 week off for 28 days
|
A Phase 1, sequential dose escalation followed by cohort expansion study of CAL-101, an oral inhibitor of PI3K delta, in patients with relapsed or refractory CLL, select B-cell NHL and AML.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has relapsed or refractory disease as defined by the following:
Disease status requirement:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford Cancer Center | |
| Palo Alto, California, United States, 94304-5548 | |
| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer Center at John Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Weill Medical College of Cornell | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792-5156 | |
More Information
| Responsible Party: | Langdon Miller, M.D., VP Clinical Research, Onoclogy, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00710528 History of Changes |
| Other Study ID Numbers: | 101-02 |
| Study First Received: | July 1, 2008 |
| Last Updated: | May 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
CLL NHL AML MM Phosphatidylinositol 3-kinase |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid, Acute Leukemia, Myeloid Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Neoplasms by Site |