An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study
NCT ID: NCT01090414
Last Updated: 2019-08-28
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
202 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-03-22
Study Completion Date
2018-06-18
Brief Summary
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This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib 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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.
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Detailed Description
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Conditions
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Chronic Lymphocytic Leukemia
Lymphoma, Non-Hodgkin
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Idelalisib
Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity.
Group Type
EXPERIMENTAL
Idelalisib
Intervention Type
DRUG
Idelalisib tablets or capsules administered orally
Interventions
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Idelalisib
Idelalisib tablets or capsules administered orally
Intervention Type
DRUG
Other Intervention Names
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Zydelig®
GS-1101
CAL-101
Eligibility Criteria
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Inclusion Criteria
* Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
* Women of childbearing potential must have a negative pregnancy test to be eligible
* Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol
* Women of childbearing potential must have a negative pregnancy test to be eligible
* Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol
Exclusion Criteria
* Patients who are unwilling or unable to comply with the protocol are not eligible
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Gilead Sciences
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Clearview Cancer Institute
Huntsville, Alabama, United States
Site Status
UCLA
Los Angeles, California, United States
Site Status
Stanford Cancer Center
Palo Alto, California, United States
Site Status
Center for Cancer & Blood Disorders, PC
Bethesda, Maryland, United States
Site Status
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Long Island Jewish medical Center
New Hyde Park, New York, United States
Site Status
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Site Status
Weill Medical College of Cornell
New York, New York, United States
Site Status
Mount Sinai School of Medicine
New York, New York, United States
Site Status
The Ohio State University Medical Center
Columbus, Ohio, United States
Site Status
Oregon Health & Science University
Portland, Oregon, United States
Site Status
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Site Status
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Site Status
MD Anderson Cancer and Research Center
Houston, Texas, United States
Site Status
MD Anderson Cancer Center
Houston, Texas, United States
Site Status
Yakima Regional Cancer Care
Yakima, Washington, United States
Site Status
University of Wisconsin
Madison, Wisconsin, United States
Site Status
Countries
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United States
References
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Barrientos J, Coutre SE, et al. (2014). Long-Term Follow-Up of a Phase 1 Trial of Idelalisib (ZYDELIG®) in Combination with Bendamustine, Bendamustine/Rituximab, Fludarabine, Chlorambucil, or Chlorambucil/Rituximab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) [Abstract 3343]. 56th American Society of Hematology (ASH) Annual Meeting and Exposition, San Francisco, California.
Reference Type
RESULT
Barrientos JC, Leonard JP, et al. (2013). Update on a Phase 1 Study of the Selective PI3Kδ Inhibitor, Idelalisib (GS-1101) in Combination with Rituximab and/or Bendamustine in Patients with Relapsed or Refractory CLL [Presentation]. American Society for Clinical Oncology (ASCO) Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Barrientos JC, Wagner-Johnston ND, et al. (2013). Chemo-Immunotherapy Combination of Idelalisib with Bendamustine/Rituximab or Chlorambucil/Rituximab in Patients with Relapsed/ Refractory CLL Demonstrates Efficacy and Tolerability [Poster 4176]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.
Reference Type
RESULT
Barrientos JC, Sharman J, et al. (2012). GS-1101 (CAL-101), A Selective Phosphatidylinositol 3-Kinase-Delta Inhibitor, in Combination With Ofatumumab for the Treatment of Relapsed/ Refractory CLL [Abstract 1062]. Haematologica: the Hematology Journal 17th Congress of the European Hematology Association 14-17 June 2012 Amsterdam; Netherlands 97 (Suppl 1): 433.
Reference Type
RESULT
Benson D, Kahl BS, et al. (2013). Final Results of a Phase 1 Study of Idelalisib, a Selective Inhibitor of PI3Kδ, in Patients with Relapsed or Refractory Indolent non-Hodgkin Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Brown JR, Cheson BD, et al. (2015). Patterns of Lymphocytosis in Patients with CLL or Small Lymphocytic Lymphoma (SLL) Treated with Idelalisib. 57th ASH Annual Meeting and Exposition, Orlando, Florida.
Reference Type
RESULT
Brown JR, Byrd JC, Coutre SE, Benson DM, Flinn IW, Wagner-Johnston ND, Spurgeon SE, Kahl BS, Bello C, Webb HK, Johnson DM, Peterman S, Li D, Jahn TM, Lannutti BJ, Ulrich RG, Yu AS, Miller LL, Furman RR. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110delta, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014 May 29;123(22):3390-7. doi: 10.1182/blood-2013-11-535047. Epub 2014 Mar 10.
Reference Type
RESULT
Brown JR, Furman RR, et al. (2013). Final Results of a Phase 1 Study of Idelalisib (GS-1101) a Selective Inhibitor of Phosphatidylinositol 3-Kinase p110 Delta (PI3Kδ) in Patients with Relapsed or Refractory CLL [Presentation]. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Coutre SE, Flinn IW, de Vos S, Barrientos JC, Schreeder MT, Wagner-Johnson ND, Sharman JP, Boyd TE, Fowler N, Dreiling L, Kim Y, Mitra S, Rai K, Leonard JP, Furman RR. Idelalisib in Combination With Rituximab or Bendamustine or Both in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia. Hemasphere. 2018 Apr 25;2(3):e39. doi: 10.1097/HS9.0000000000000039. eCollection 2018 Jun.
Reference Type
RESULT
Coutre S, Barrientos C, et al. (2015). Safety of Idelalisib in B-cell Malignancies: Integrated Analysis of Eight Clinical Trials. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Coutre S, Leonard J, et al. (2015). Idelalisib Monotherapy Results in Durable Responses in Patients with Relapsed or Refractory Waldenstrom's Macroglobulinemia. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
DeVos S, Wagner-Johnston ND, et al. (2014). Durable Responses Following Treatment with the PI3K-Delta Inhibitor Idelalisib in Combination with Rituximab, Bendamustine, or Both, in Recurrent Indolent non-Hodgkin Lymphoma: Phase I/II Results [Abstract 3063]. 56th ASH Annual Meeting and Exposition, San Francisco, California.
Reference Type
RESULT
DeVos S, Furman RR, et al. (2013). Idelalisib, a Selective Inhibitor of PI3Kδ, in Combination with Bendamustine, Fludarabine, or Chlorambucil in Patients with Relapsed or Refractory (R/R) CLL [Poster 2878]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.
Reference Type
RESULT
Flinn IW, Kahl BS, Leonard JP, Furman RR, Brown JR, Byrd JC, Wagner-Johnston ND, Coutre SE, Benson DM, Peterman S, Cho Y, Webb HK, Johnson DM, Yu AS, Ulrich RG, Godfrey WR, Miller LL, Spurgeon SE. Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-delta, as therapy for previously treated indolent non-Hodgkin lymphoma. Blood. 2014 May 29;123(22):3406-13. doi: 10.1182/blood-2013-11-538546. Epub 2014 Mar 10.
Reference Type
RESULT
Furman R, DeVos S, et al. (2014). Long-Term Follow-Up of a Phase 1 Study of Idelalisib (ZYDELIG®) in Combination with Anti-CD20 Antibodies (Rituximab or Ofatumumab) in Patients with Relapsed or Refractory CLL. 56th ASH Annual Meeting and Exposition, San Francisco, California.
Reference Type
RESULT
Furman R, Sharman J, et al. (2013). A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib and Rituximab for Previously Treated Patients with CLL [Abstract LBA-6]. 55th ASH Annual Meeting and Exposition, New Orleans, Louisiana.
Reference Type
RESULT
Ghia P, Cheson BD, et al. (2016). Patterns of Idelalisib Treatment-Emergent Lymphocytosis in Patients with CLL or SLL [poster]. EHA 21st Congress, Copenhagen, Denmark.
Reference Type
RESULT
Ghia P, Coutre S, et al. (2016). Management of Transaminase Elevations Associated with Idelalisib [poster]. European Hematology Association (EHA) 21st Congress, Copenhagen, Denmark.
Reference Type
RESULT
Gopal AK, Davies AJ, et al. (2015). Idelalisib Monotherapy and Durable Responses in Patients with Relapsed or Refractory SLL. 57th ASH Annual Meeting and Exposition, Orlando, Florida.
Reference Type
RESULT
Kahl BS, Spurgeon SE, Furman RR, Flinn IW, Coutre SE, Brown JR, Benson DM, Byrd JC, Peterman S, Cho Y, Yu A, Godfrey WR, Wagner-Johnston ND. A phase 1 study of the PI3Kdelta inhibitor idelalisib in patients with relapsed/refractory mantle cell lymphoma (MCL). Blood. 2014 May 29;123(22):3398-405. doi: 10.1182/blood-2013-11-537555. Epub 2014 Mar 10.
Reference Type
RESULT
Leonard JP, Wagner-Johnston ND, et al. (2013). Combinations of the PI3Kδ Inhibitor Idelalisib (GS-1101) with Rituximab and/or Bendamustine are Tolerable and Highly Active in Patients with Previously Treated, Indolent non-Hodgkin Lymphoma: Updated Results from a Phase I Study [Presentation]. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Martin P, Armas A, et al. (2015). Idelalisib Monotherapy and Durable Responses in Patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL). 57th ASH Annual Meeting and Exposition, Orlando, Florida.
Reference Type
RESULT
O'Brien SM, Lamanna N, Kipps TJ, Flinn I, Zelenetz AD, Burger JA, Keating M, Mitra S, Holes L, Yu AS, Johnson DM, Miller LL, Kim Y, Dansey RD, Dubowy RL, Coutre SE. A phase 2 study of idelalisib plus rituximab in treatment-naive older patients with chronic lymphocytic leukemia. Blood. 2015 Dec 17;126(25):2686-94. doi: 10.1182/blood-2015-03-630947. Epub 2015 Oct 15.
Reference Type
RESULT
O'Brien SM, Lamanna N, et al. (2014). Update on a Phase 2 Study of Idelalisib in Combination with Rituximab in Treatment-Naive Patients ≥ 65 Years with CLL or SLL [Poster 1994]. 56th ASH Annual Meeting and Exposition, San Francisco, California.
Reference Type
RESULT
O'Brien SM, Lamanna N, et al. (2013). A Phase 2 Study of the Selective Phosphatidylinositol 3-Kinase Delta (PI3Kδ) Inhibitor Idelalisib (GS-1101) in Combination with Rituximab in Treatment-Naive Patients ≥ 65 Years with CLL or SLL [Presentation]. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Spurgeon SE, Wagner-Johnston ND, et al. (2013). Final Results of a Phase 1 Study of Idelalisib, a Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ (PI3Kδ) in Patients with Relapsed or Refractory Mantle Cell Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Wagner-Johnston ND, DeVos S, et al. (2013). Preliminary Results of PI3Kδ Inhibitor Idelalisib (GS-1101) Treatment in Combination with Everolimus, Bortezomib, or Bendamustine/Rituximab in Patients with Previously Treated Mantle Cell Lymphoma [Presentation]. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
Wierda W, Coutre S, et al. (2016). Management of Transaminase Elevations in Patients Receiving Idelalisib. ASCO Annual Meeting, Chicago, Illinois.
Reference Type
RESULT
de Vos S, Wagner-Johnston ND, Coutre SE, Flinn IW, Schreeder MT, Fowler NH, Sharman JP, Boccia RV, Barrientos JC, Rai KR, Boyd TE, Furman RR, Kim Y, Godfrey WR, Leonard JP. Combinations of idelalisib with rituximab and/or bendamustine in patients with recurrent indolent non-Hodgkin lymphoma. Blood Adv. 2016 Nov 30;1(2):122-131. doi: 10.1182/bloodadvances.2016000976. eCollection 2016 Dec 13.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Study Protocol: Amendment 4
Document Type: Study Protocol: Amendment 5
Document Type: Study Protocol: Amendment 6
Document Type: Statistical Analysis Plan
Other Identifiers
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101-99
Identifier Type: -
Identifier Source: org_study_id
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