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BKM120 as Second-line Therapy for Advanced Endometrial Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01289041
First received: January 26, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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: Allocation: Non-Randomized
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

Resource links provided by NLM:

U.S. FDA Resources

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: 113
Study Start Date: February 2011
Estimated Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BKM120 Drug: BKM120

  Eligibility

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

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

  Show 44 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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: April 15, 2013
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

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on June 18, 2013