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: 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-GB

Lead Sponsor: Incyte Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of INCB050465 in terms of objective response rate (ORR) in subjects with relapsed or refractory DLBCL who were not previously treated with a BTK inhibitor (group A).;Secondary Objective: • To assess the duration of response (DOR) in subjects who were not previously treated with a BTK inhibitor (group A)<br>• To assess progression-free survival (PFS) in group A<br>• To assess overall survival (OS) in group A<br>• To characterize the safety of INCB050465;Primary end point(s): ORR in Group A, defined as the percentage of subjects with a complete response/complete metabolic response (CR/CMR) or partial response/partial metabolic response (PR/PMR) as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an Independent Review Committee.;Timepoint(s) of evaluation of this end point: Up to 2 years after the first dose is administered to the last subject enrolled

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • DOR in Group A, defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression or death from any cause among subjects who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.<br>• PFS in Group A, defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.<br>• OS in Group A, defined as the time from the date of the first dose of study drug until death by any cause.<br>• Safety as measured by clinical assessments, including vital signs and physical examinations, 12-lead electrocardiograms (ECG), chemistry and hematology laboratory values, and adverse events (AEs).;Timepoint(s) of evaluation of this end point: Up to 2 years after the first dose is administered to the last subject enrolled

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