BKM120 as Second-line Therapy for Advanced Endometrial Cancer

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: January 26, 2011
Last updated: November 7, 2014
Last verified: November 2014

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

Condition Intervention Phase
Advanced Endometrial Cancer
Drug: BKM120
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Determine the efficacy of BKM120 (parameter: Overall Response Rate) in all patients and patients with an activated PI3K pathway status [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the efficacy of BKM120 (parameter: Overall Response Rate) in patients with a non-activated PI3K pathway status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate additional efficacy parameters (Time to Response, Duration of Response, Progression Free Survival, Overall Survival) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluate safety of BKM120 (frequency and severity of adverse events, number of lab values worsening form baseline based on the Common Terminology Criteria of Adverse Events (CTCAE) grade) [ Time Frame: up to 30 days after treatment discontinuation ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: February 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM120 Drug: BKM120


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01289041

  Show 42 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01289041     History of Changes
Other Study ID Numbers: CBKM120C2201, 2010-022015-19
Study First Received: January 26, 2011
Last Updated: November 7, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Institute of Health
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health

Keywords provided by Novartis:
Advanced endometrial cancer
PI3K pathway
second-line treatment

ClinicalTrials.gov processed this record on March 26, 2015