Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Bayer

Status and phase

Terminated

Phase 2

Conditions

Lymphoma, Mantle-Cell

Treatments

Drug: Copanlisib (BAY80-6946)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02455297

17120

Details and patient eligibility

About

The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed MCL
Patients who have previously received treatment with ibrutinib (modified by amendment 1), including:
- Completion of at least 1 cycle of treatment with ibrutinib and confirmed evidence of disease progression or refractoriness to treatment or
- Discontinuation of ibrutinib treatment at an earlier time due to toxicity
Measurable disease according to the Lugano Classification
At least 28 days or 5 half-lives, whichever is shorter, from the completion of anti-cancer treatment (including, but not limited to, immunotherapy, chemotherapy, targeted therapy and biologic therapy) to the start of study treatment, excluding ibrutinib where the window may be less and at minimum 3 days (modified by amendment 1)
Availability of fresh tumor tissue at screening
Male or female patients ≥ 18 years old
ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
Left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan ≥ the lower limit of normal (LLN) for the Institution
Adequate bone marrow, liver and renal function

Exclusion criteria

Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only
Current central nervous system (CNS) involvement by lymphoma
New York Heart Association (NYHA) class III or IV heart disease
Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatment
Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment) (modified by amendment 1)
Type I or II diabetes mellitus with HbA1c > 8.5% at screening (modified by amendment 1)
Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study treatment. However, if a patient has recovered to ECOG performance status of ≤ 2 he/she may be enrolled provided that other eligibility criteria are met
Ongoing or active infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3
Known history of human immunodeficiency virus (HIV) infection
Acute or chronic hepatitis B (HBV) or hepatitis C (HCV) infection requiring concomitant treatment prohibited by this protocol (i.e.immunosuppressive therapy)
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
Prior treatment with PI3K inhibitor(s)
Cytomegalovirus (CMV) PCR positive at baseline