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A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

Phase 2
18 Years
Open (Enrolling)
Advanced Endometrial Cancer

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Trial Information

A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

Inclusion Criteria:

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

- histologically confirmed diagnosis of advanced endometrial carcinoma with available
tissue specimen for identification of PI3K pathway activation (archival tissue or a
fixed fresh biopsy)

- one prior line of antineoplastic treatment with a cytotoxic agent

- objective progression of disease after prior treatment and at least one measurable
lesion as per RECIST criteria

- adequate bone marrow and organ function

Exclusion Criteria:

- previous treatment with PI3K and/or mTOR inhibitors

- symptomatic CNS metastases

- concurrent malignancy or malignancy within 3 years of study enrollment

- Active mood disorder as judged by investigator or medically documented history of
mood disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive
disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety

- pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study

- poorly controlled diabetes mellitus (HbA1c > 8 %)

- history of cardiac dysfunction or active cardiac disease as specified in the protocol

- impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of BKM120

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the efficacy of BKM120 (parameter: Overall Response Rate) in all patients and patients with an activated PI3K pathway status

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

May 2013

Related Keywords:

  • Advanced Endometrial Cancer
  • Advanced endometrial cancer
  • PI3K pathway
  • second-line treatment
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



Cancer Care Northwest CC Northwest- Spokane South(3) Spokane, Washington  99202
Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville, Arkansas  72703
Sarah Cannon Research Institute SCRI (2) Chattanooga, Tennessee  37404
Texas Oncology, P.A. Austin Bedford, Texas  76022
South Texas Oncology and Hematology, PA South Tex Onc San Antonio, Texas  78258
St. Joseph's Hospital & Medical Center St Jospeh's Phoenix, Arizona  85013
Morristown Memorial Hospital MMH Morristown, New Jersey  07962
Carolinas HealthCare Systems Blumenthal Cancer Center Charlotte, North Carolina  28207
University of Oklahoma Health Sciences Center OU Health Oklahoma City, Oklahoma  73104