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A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Matthew S. Davids, MD, Dana-Farber Cancer Institute
Sponsor:
Collaborators:
TG Therapeutics, Inc.
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Matthew S. Davids, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02268851
First received: October 16, 2014
Last updated: September 7, 2016
Last verified: September 2016
  Purpose
This research study will be evaluating the safety and efficacy of a study drug called TGR-1202 in combination with a known drug ibrutinib, also known as Imbruvica, as a possible treatment for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Mantle Cell Lymphoma (MCL) that has come back or that has not responded to standard treatment.

Condition Intervention Phase
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Mantle Cell Lymphoma Drug: TGR-1202 Drug: Ibrutinib Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of the Novel PI3k Delta Inhibitor TGR-1202 in Combination With Ibrutinib in Patients With Select B-Cell Malignancies

Resource links provided by NLM:


Further study details as provided by Matthew S. Davids, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • MTD of TGR-1202 [ Time Frame: 2 Years ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: 2 years ]
  • Rate of nodal response with lymphocytosis (nPR) [ Time Frame: 2 years ]
  • Rate of Progression Free Survival [ Time Frame: 2 Years ]
  • Duration of Response [ Time Frame: 2 Years ]

Estimated Enrollment: 60
Study Start Date: November 2014
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TGR-1202

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.
Drug: TGR-1202
Capsules taken whole daily with water and with food
Other Name: RP5264
Drug: Ibrutinib
Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
Other Names:
  • Imbruvica
  • CRA-032765
  • PCI-32765

Detailed Description:

This research study is a Phase I and Ib combination clinical trial, which aims to both evaluate the safety of an investigational drug combination and also tries to define the appropriate dose of the investigational drug to evaluate in later clinical trials. "Investigational" means that the intervention is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved TGR-1202 in the United States for use in MCL/CLL/SLL cancers.

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL)
  • 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:-

  • Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) within 3 weeks of Cycle 1/Day 1,
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02268851

Contacts
Contact: Matthew Davids, MD 617-632-6331 matthew_davids@dfci.harvard.edu

Locations
United States, California
Pacific Cancer Care Recruiting
Monterey, California, United States, 93940
Contact: Laura Stampleman, MD         
Contact: Monica Castillo    831-375-4105 ext 1077      
United States, Connecticut
St. Francis Hospital and Cancer Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Adam Boruchov, MD         
Contact    860-714-4000      
United States, Georgia
Northside Hospital and Cancer Center Recruiting
Atlanta, Georgia, United States, 30342
Contact: Asad Bashey, MD         
Contact: Stacey Brown    404-851-8238      
United States, Maine
Eastern Maine Medical Center Recruiting
Brewer, Maine, United States, 04412
Contact: Jens Rueter, MD         
Contact: Laurie Lewis    207-973-4249      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Matthew Davids, MD    617-632-5847      
Principal Investigator: Matthew Davids, MD         
Beth Israel Deaconness Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jon Arnason, MD         
Contact    617-667-9920      
United States, Michigan
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Don Park, MD       dpark@wmcc.org   
Contact: Joan Westendorp, RN       jwestendorp@wmcc.org   
United States, Washington
Kadlec Clinic Hematology Oncology Completed
Kennewick, Washington, United States, 99336
Sponsors and Collaborators
Dana-Farber Cancer Institute
TG Therapeutics, Inc.
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Matthew Davids, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Matthew S. Davids, MD, Principal Investigators, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02268851     History of Changes
Other Study ID Numbers: 14-396
TGR-IB-105 ( Other Identifier: TG Therapeutics )
Study First Received: October 16, 2014
Last Updated: September 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Matthew S. Davids, MD, Dana-Farber Cancer Institute:
Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Additional relevant MeSH terms:
Lymphoma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Leukemia, B-Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on June 26, 2017