A phase 2, multicenter, international, open-label, safety and efficacy study of INCB050465 in patients with relapsed or refractory diffuse large B-cell lymphoma.

Phase 1

• Conditions: Diffuse large B-cell lymphoma; MedDRA version: 19.1Level: 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-CZ
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-30
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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