BKM120 as Second-line Therapy for Advanced Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289041
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Endometrial Cancer Drug: BKM120 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: All Patients Drug: BKM120
Other Name: Buparlisib

Primary Outcome Measures :
  1. Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status [ Time Frame: 24 months ]

    BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines.

    BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR od SD >= 24 weeks)

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) According to PI3K Activation Pathway Status [ Time Frame: 24 months ]
    PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.

  2. Overall Survival (OS) According to PI3K Activation Pathway Status [ Time Frame: every 3 months ]
    Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01289041

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01289041     History of Changes
Other Study ID Numbers: CBKM120C2201
2010-022015-19 ( EudraCT Number )
First Posted: February 3, 2011    Key Record Dates
Results First Posted: April 10, 2015
Last Update Posted: April 10, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female