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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 GrpFayetteville, Arkansas  72703
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Morristown Memorial Hospital MMHMorristown, New Jersey  07962
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