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

Part of paid clinical trials in Monterey, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02268851
Phase
PHASE1
Status
Completed

Conditions

  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TGR-1202 — DRUG
    Capsules taken whole daily with water and with food
  • Ibrutinib — DRUG
    Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges

Study Details

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.

Key Dates

Start date
Nov 30, 2014
Status verified
Sep 2024
Primary completion
May 31, 2018
Completion
Oct 31, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I [ Time Frame: Participants were assessed every week or more often as needed during Cycle 1 or more often for up to 28 days to assess Dose-limiting toxicities (DLTs) during Phase I ]

Locations (5)

FacilityCityStateZIPSite coordinators
Pacific Cancer CareMontereyCalifornia93940-
St. Francis Hospital and Cancer CenterHartfordConnecticut06105-
Eastern Maine Medical Center/ Northern Light Cancer CareBrewerMaine04412-
Beth Israel Deaconness Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Monterey, CA

By research site
Pacific Cancer Care· Monterey, CASt. Francis Hospital and Cancer Center· Hartford, CTEastern Maine Medical Center/ Northern Light Cancer Care· Brewer, MEBeth Israel Deaconness Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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