A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02403271
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.

Key Dates

Start date
Mar 31, 2015
Status verified
Dec 2018
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
124 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b
    In the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 will be explored and will follow a 6+3 dose de-escalation design and will include a sentinel participant which will have a 3-day observation period prior to dosing of subsequent participants. Participants with one of the following three tumor types will be eligible for enrollment: NSCLC (adenocarcinoma and squamous-cell carcinoma), Breast cancer (triple-negative and HER2-positive cancer), and Pancreatic cancer (adenocarcinoma).
  • Experimental: Phase 2
    Participants with one of three solid tumor types (Stage III/IV) will be enrolled in the Phase 2 portion of this protocol: NSCLC (adenocarcinoma and squamous-cell carcinoma), Breast cancer (triple-negative and HER2-positive cancer), and Pancreatic cancer (adenocarcinoma) and treated at the R2PD of ibrutinib and durvalumab determined in Phase 1b. An interim analysis will be performed to evaluate the response and the safety profile, and the study may be discontinued based on the interim efficacy and/or safety results.

Primary Outcome Measure

Phase 1b: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Durvalumab (MEDI4736) and to Find the Recommended Phase II Dose. [ Time Frame: From the date of first study treatment until DLT or disease progression per RECIST 1.1. ]

Locations (17)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35294-
-ScottsdaleArizona85258-
-La JollaCalifornia92093-
-Los AngelesCalifornia90025-
-Los AngelesCalifornia90048-
-Palo AltoCalifornia94305-
-San FranciscoCalifornia94115-
-GainesvilleFlorida32610-
-OrlandoFlorida32806-
-ChicagoIllinois60637-
-PeoriaIllinois61615-
-HackensackNew Jersey07601-
-DurhamNorth Carolina27710-
-GermantownTennessee38120-
-NashvilleTennessee37212-
-HoustonTexas77030-
-San AntonioTexas78229-

Find similar trials in Birmingham, AL

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Breast cancerLung cancerPancreatic cancer
By specialty
OncologyBreast oncologyWomen's healthLung oncologyLung diseaseGI oncology

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