A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
NCT ID: NCT02268851
Last Updated: 2024-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2014-11-30
2022-10-31
Brief Summary
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Detailed Description
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TGR-1202 is a newly developed drug that may stop cancer cells from growing based on recent laboratory experiments. The results from these experiments suggest this drug may help to kill cancer cells when coupled with ibrutinib. In this research study, the safety and tolerability of TGR-1202 is being investigated to determine the highest dose that can safely be used in combination with ibrutinib. The study is also aimed to evaluate whether TGR-1202 has any effect on tumor growth (nodal response), and to determine the overall repsonse rate and duration of response in patients with CLL/SLL or MCL
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CLL
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
* Each Cycle = 28 days
* TGR-1202 (oral): Starting on Day 1 administered daily.
* Ibrutinib (oral): Starting on Day 1 administered daily.
TGR-1202
Capsules taken whole daily with water and with food
Ibrutinib
Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
MCL
Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation.
* Each Cycle = 28 days
* TGR-1202 (oral): Starting on Day 1 administered daily.
* Ibrutinib (oral): Starting on Day 1 administered daily.
TGR-1202
Capsules taken whole daily with water and with food
Ibrutinib
Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
Interventions
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TGR-1202
Capsules taken whole daily with water and with food
Ibrutinib
Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate organ system function ( Absolute neutrophil count, Platelets,Bilirubin, Platelets, Aspartate transferase ,Alanine aminotransferase, Creatinine Clearance)
* Eastern Cooperative Group (ECOG) Performance status ≤ 2
* Ability to swallow and retain oral medication
* Female patients: must have negative serum pregnancy test at study screening/ all male partners must consent to use a medically acceptable method of contraception
* Willingness and ability to comply with trial and follow-up procedures, and give written informed consent
Exclusion Criteria
* Autologous hematologic stem cell transplant within 3 months of study entry.
* Allogeneic hematologic stem cell transplant within 12 months.
* Post-allo patients must not have active graft versus-host disease
* Evidence of active Hepatitis B,Hepatitis C or HIV infection.
* Active central nervous system involvement by lymphoma
* Requires treatment with strong CYP3A4/5 inhibitors
* Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* QTcF \>470 msec (QT interval, Fredericia calculation)
* Angina not well-controlled by medication
* Poorly controlled or clinically significant atherosclerotic vascular disease
* Presence of other active cancers, or history of treatment for invasive cancer within the past 2 years.
* Require warfarin for anticoagulation
* Women who are pregnant or lactating
18 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
The Leukemia and Lymphoma Society
OTHER
Blood Cancer Research Partnership
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Matthew S. Davids, MD
Principal Investigators
Principal Investigators
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Matthew Davids, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Pacific Cancer Care
Monterey, California, United States
St. Francis Hospital and Cancer Center
Hartford, Connecticut, United States
Eastern Maine Medical Center/ Northern Light Cancer Care
Brewer, Maine, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
Countries
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References
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Davids MS, Kim HT, Nicotra A, Savell A, Francoeur K, Hellman JM, Bazemore J, Miskin HP, Sportelli P, Stampleman L, Maegawa R, Rueter J, Boruchov AM, Arnason JE, Jacobson CA, Jacobsen ED, Fisher DC, Brown JR; Blood Cancer Research Partnership of the Leukemia and Lymphoma Society. Umbralisib in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia or mantle cell lymphoma: a multicentre phase 1-1b study. Lancet Haematol. 2019 Jan;6(1):e38-e47. doi: 10.1016/S2352-3026(18)30196-0. Epub 2018 Dec 14.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TGR-IB-105
Identifier Type: OTHER
Identifier Source: secondary_id
14-396
Identifier Type: -
Identifier Source: org_study_id
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