An Extension Study for Patients Who Are Deriving Benefit With CAL-101 to Continue on Treatment at the End of the Current Study (101-99)
This study is currently recruiting participants.
Verified January 2013 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01090414
First received: March 17, 2010
Last updated: January 12, 2013
Last verified: January 2013
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Purpose
This extension study provides the opportunity for patients with hematologic malignancies who complete a prior CAL-101 study protocol to continue idelilisib (CAL-101, GS-1101) 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Leukemia
Lymphoma
Multiple Myeloma
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Safety [ Time Frame: Approximately every 3 months ] [ Designated as safety issue: Yes ]Adverse events will be monitored at routine standard of care visits
Secondary Outcome Measures:
- Duration of Response [ Time Frame: Approximately every 3 months ] [ Designated as safety issue: No ]Clinical response as measured by standard of care procedures (blood values, CT scan results)
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
Other Names:
|
Detailed Description:
This is a long-term safety extension study of idelilisib (CAL-101, GS-1101) 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 idelilisib (CAL-101, GS-1101) 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 idelilisib (CAL-101, GS-1101), 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 |
Criteria
Inclusion Criteria:
- Patients with hematologic malignancies completing a prior CAL-101 study with a clinical benefit are eligible
Exclusion Criteria:
- No exclusion criteria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090414
Contacts
| Contact: Sissy Peterman | 206-832-2015 | speterman@gilead.com |
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 | |
| Moores UCSD Cancer Center | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Jesika Reiner 858-822-5364 jreiner@ucsd.edu | |
| Principal Investigator: Thomas Kipps, MD, PhD | |
| 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: Tessa St. Rose 650-736-4032 TessaSt.Rose1@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 | |
| Long Island Jewish medical Center | Recruiting |
| New Hyde Park, New York, United States, 11042 | |
| Contact: Jason Light 718-470-4743 jlight@nshs.edu | |
| Principal Investigator: Jacqueline Barrientos, MD | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Nicole Lamanna, MD 212-639-2279 lamannan@mskcc.org | |
| Principal Investigator: Nicole Lamanna, MD | |
| 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 | 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 | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Barbie Jackson 503-494-9916 jacksoba@ohsu.edu | |
| Principal Investigator: Stephen Spurgeon, M.D. | |
| Willamette Valley Cancer Institute and Research Center | Recruiting |
| Springfield, Oregon, United States, 97477 | |
| Contact: Jeanne Schaffer, RN 541-521-8773 Jeanne.Schaffer@USOncology.com | |
| Principal Investigator: Jeff Sharman, MD | |
| 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 | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Rochelle Allen 713-745-2715 rdallen@mdanderson.org | |
| Principal Investigator: Nathan Fowler, MD | |
| United States, Washington | |
| Yakima Regional Cancer Care | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact: Jo Cook, RN 509-574-3486 jo.cook@yvmh.org | |
| Principal Investigator: Thomas Boyd, 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 | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Thomas Jahn, MD | Gilead Sciences |
More Information
No publications provided
| 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 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
idelilisib CLL NHL |
AML MM Phosphatidylinositol 3-kinase |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013