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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Non-Hodgkin

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Trial Information

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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response

Outcome Description:

Objective tumor response (OR) is defined as best response rating of complete response (CR or unconfirmed CR) or partial response (PR) according to the criteria defined in the Report of an International Workshop to Standardize Response Criteria for NHL. In patients with Chronic lymphocytic leukemia (CLL), OR is defined as best response rating of complete response (CR) or partial response (PR) according to the guidelines for the diagnosis and treatment of chronic lymphocytic leukemia of the International Workshop on Chronic Lymphocytic Leukemia.

Outcome Time Frame:

Up to 10 months

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

16349

NCT ID:

NCT01660451

Start Date:

November 2012

Completion Date:

April 2017

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Clinical trial, phase II
  • Phosphatidylinositol 3-Kinase
  • Class I, Non-Hodgkin's lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Great Falls, Montana  59405
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Flint, Michigan  48532
Kansas City, Kansas  66160
Scarborough, Maine  04074
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Denver, Colorado  
Baltimore, Maryland  21287
Indianapolis, Indiana  
Charleston, South Carolina