A phase 2, multicenter, international, open-label, safety and efficacy studyof INCB050465 in patients with relapsed or refractory diffuse large B-celllymphoma.
- Conditions
- Diffuse large B-cell lymphomaMedDRA version: 21.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002205-19-IT
- Lead Sponsor
- INCYTE CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
• Men and women, aged 18 years or older.
• Relapsed or refractory DLBCL, which has been histologically
documented, defined as having received at least 2 but no more than 5
prior treatment regimens (eg, an anti-CD20 antibody, an anti-CD20
antibody with or without chemotherapy, or chemotherapy alone) and
ineligible for high-dose chemotherapy supported by autologous stem cell
transplant.
• Must have = 1 measurable (= 2 cm in longest dimension) or = 1
measurable extranodal lesion (> 1 cm in longest dimension) lesion on
computed tomography (CT) scan or magnetic resonance imaging (MRI).
• Subjects must be willing to undergo an incisional or excisional lymph
node biopsy of accessible adenopathy or provide the most recent,
available archived tumor biopsy.
• Eastern Cooperative Oncology Group performance status 0 to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
• Primary mediastinal (thymic) large B-cell lymphoma.
• Known brain or central nervous system metastases or history of
uncontrolled seizures.
• Allogeneic stem cell transplant within the last 6 months, or active graft
versus host disease following allogeneic transplant, or autologous stem
cell transplant within the last 3 months.
• Use or expected use during the study of any prohibited medications,
including potent cytochrome P450 3A4 inhibitors or inducers within 14
days or 5 half-lives (whichever is longer) before the first dose of study
drug.
• Prior treatment with the following:
- Group A: Prior treatment with a selective phosphatidylinositol 3-
kinase (PI3K) d inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK
inhibitor (eg, ibrutinib).
- Group B: Prior treatment with a selective PI3Kd inhibitor (eg,
idelalisib) or a pan-PI3K inhibitor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method