Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

Inclusion Criteria:

- Indolent Non-Hodgkin's lymphoma (NHL):

- Histologically confirmed diagnosis of Grade 1, 2 or 3a follicular lymphoma (FL),
marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma
and mucosa-associated lymphoid tissue [MALT] lymphoma), lymphoplasmacytic
lymphoma/Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL)

- Relapsed after ≥ 2 prior chemotherapy- or immunotherapy-based regimens for
indolent NHL, or refractory to 2 prior chemotherapy- and/or immunotherapy-based
regimens

- Aggressive NHL:

- Histologically confirmed diagnosis of Grade 3b follicular lymphoma (FL),
transformed indolent lymphoma, diffuse large B-cell lymphoma, mediastinal large
B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma, or
anaplastic large cell lymphoma

- Relapsed after ≥ 2 prior chemotherapy regimens, including the following:
first-line treatment with standard anthracycline-containing regimen (e.g.
cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At
least 1 additional combination chemotherapy regimen. Patients refractory to
first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL
and not eligible for high-dose regimen followed by transplant. High-dose
chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is
considered 1 regimen. Patients with CD20 (cluster of differentiation) expressing
neoplastic cells must have received prior rituximab, if available.

- Applicable to all patients

- Male or female patients > 18 years of age

- Patients with NHL must have at least one measurable lesion according to the
recommendations of the Report of an International Workshop to Standardize
Response Criteria for NHL

- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

- Life expectancy of at least 3 months

- Availability of archival tumor tissue

Exclusion Criteria:

- Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg despite optimal medical
management)

- Current diagnosis of Type 1 or 2 diabetes mellitus, fasting blood glucose > 125 mg/dL
(> 6.9 mmol/L) or HbA1c ≥ 7.0 %

- Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding
event ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
of start of study medication

- History or concurrent condition of interstitial lung disease

- Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any
prior therapy/procedure excluding alopecia

- Prior treatment with PI3K inhibitors

- Systemic corticosteroid therapy (ongoing)