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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by (Responsible Party): | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01090414 |
Purpose
This extension study provides the opportunity for patients with hematologic malignancies who complete a prior CAL-101 study protocol to continue CAL-101 treatment as long as the patient is deriving clinical benefit.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia Lymphoma, Non-Hodgkin Acute Myeloid Leukemia Multiple Myeloma |
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: | An Extension Study to Investigate the Safety and Durability of Clinical Activity of CAL-101 in Patients With Hematologic Malignancies |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CAL-101 |
Drug: CAL-101
CAL-101 capsules, 50 to 350 mg, BID or QD until disease progression or unacceptable toxicity
|
This is a long-term safety extension study of CAL-101 in patients with hematologic malignancies who complete other CAL-101 studies. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of CAL-101 will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients may receive other anti-cancer therapy. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to CAL-101, or if they no longer derive clinical benefit in the opinion of the investigator.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Clearview Cancer Institute | Recruiting |
| Huntsville, Alabama, United States, 35805 | |
| Contact: Kathy Cutter, RN, BSN 256-705-4248 KathyC@ccihsv.com | |
| Principal Investigator: Marshall T Schreeder, MD | |
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1678 | |
| Contact: Audrey Roque-Tayag 310-998-4730 artayag@mednet.ucla.edu | |
| Principal Investigator: Sven deVos, MD | |
| Stanford Cancer Center | Recruiting |
| Palo Alto, California, United States, 94304-5548 | |
| Contact: Michelle Takahashi 650-736-4032 mtakaha2@stanford.edu | |
| Principal Investigator: Steven Coutre, MD | |
| United States, Maryland | |
| Center for Cancer & Blood Disorders, PC | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Christine DiSilvestre 301-571-2016 dkelley@dom.wustl.edu | |
| Principal Investigator: Ralph Boccia, MD | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Katie Mullins 617-582-8713 KatherineA_Mullins@DFCI.HARVARD.EDU | |
| Principal Investigator: Jennifer Brown, M.D. | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Justina Timm 314-362-4206 jtimm@DOM.wustl.edu | |
| Principal Investigator: Nina Wagner-Johnston, MD | |
| United States, New York | |
| Weill Medical College of Cornell | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Arcania Garcia 212-746-2062 arg2006@med.cornell.edu | |
| Principal Investigator: Richard Furman, M.D. | |
| United States, Ohio | |
| The Ohio State University Medical Center | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Mona Stefanos 614-293-9702 Mona.Stefanos@osumc.edu | |
| Principal Investigator: Don Benson, M.D. | |
| United States, Oregon | |
| Oregon Health & Science University | Not yet recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Barbie Jackson 503-494-9916 jacksoba@ohsu.edu | |
| Principal Investigator: Stephen Spurgeon, M.D. | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Meredith Zimlich 615-329-7245 Meredith.Zimlich@scresearch.net | |
| Principal Investigator: Ian Flinn, M.D. | |
| United States, Texas | |
| MD Anderson Cancer and Research Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Ana Ayala 713-792-4254 abayala@mdanderson.org | |
| Principal Investigator: Susan O'Brien, MD | |
| United States, Wisconsin | |
| University of Wisconsin | Recruiting |
| Madison, Wisconsin, United States, 53792-5156 | |
| Contact: Connie Sparks 608-265-5542 csparks@medicine.wisc.edu | |
| Principal Investigator: Brad Kahl, MD | |
More Information
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01090414 History of Changes |
| Other Study ID Numbers: | 101-99, 101-99 |
| Study First Received: | March 17, 2010 |
| Last Updated: | January 31, 2012 |
| 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 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 |
