Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies
NCT ID: NCT01796470
Last Updated: 2020-06-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
66 participants
INTERVENTIONAL
2013-06-20
2016-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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SEQUENTIAL
TREATMENT
NONE
Study Groups
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Entospletinib + idelalisib
Entospletinib plus idelalisib at one of 4 dose combinations (400 mg/100 mg; 600 mg/100 mg; 800 mg/100 mg; 800 mg/150 mg).
After discontinuation of entospletinib+idelalisib combination therapy, and following a washout period, participants may continue to receive entospletinib 400 mg monotherapy.
Entospletinib
Entospletinib tablets administered orally twice daily
Idelalisib
Idelalisib tablets administered orally twice daily
Interventions
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Entospletinib
Entospletinib tablets administered orally twice daily
Idelalisib
Idelalisib tablets administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®; GS-1101); individuals with malignancies being studied in these protocols must have failed screening and be registered as a screen failure in the respective idelalisib protocol
* Prior treatment for lymphoid malignancy
* Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
* Discontinuation of all therapy for the treatment of cancer ≥ 3 weeks before the start of study drug
* All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug
* Karnofsky performance status of ≥ 60
* Life expectancy of at least 3 months
Exclusion Criteria
* Known active central nervous system or leptomeningeal lymphoma
* Presence of known intermediate- or high-grade myelodysplastic syndrome
* Current therapy with agents that reduce gastric acidity, including but not limited to antacids, H2 inhibitors, and proton pump inhibitors
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug
* Ongoing liver injury
* Ongoing or recent hepatic encephalopathy
* Ongoing drug-induced pneumonitis
* Ongoing inflammatory bowel disease
* Ongoing alcohol or drug addiction
* Pregnancy or breastfeeding
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy
* Concurrent participation in an investigational drug trial with therapeutic intent
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, United States
Cancer Center of Santa Barbara
Santa Barbara, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Collaborative Research Group LLC
Boynton Beach, Florida, United States
Weill Cornell Medical College
New York, New York, United States
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Charleston Hematology Oncology
Charleston, South Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Countries
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References
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Barr PM, Saylors GB, Spurgeon SE, Cheson BD, Greenwald DR, O'Brien SM, Liem AK, Mclntyre RE, Joshi A, Abella-Dominicis E, Hawkins MJ, Reddy A, Di Paolo J, Lee H, He J, Hu J, Dreiling LK, Friedberg JW. Phase 2 study of idelalisib and entospletinib: pneumonitis limits combination therapy in relapsed refractory CLL and NHL. Blood. 2016 May 19;127(20):2411-5. doi: 10.1182/blood-2015-12-683516. Epub 2016 Mar 11.
Other Identifiers
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GS-US-339-0103
Identifier Type: -
Identifier Source: org_study_id
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