Clinical trial NCT01289041: BKM120 as Second-line Therapy for Advanced Endometrial Cancer
Official title: A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Endometrial Cancer
Keywords: Advanced endometrial cancer
PI3K pathway
second-line treatment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
timeFrame: 24 months
Secondary outcomes:
measure: Progression Free Survival (PFS) According to PI3K Activation Pathway Status
timeFrame: 24 months
measure: Overall Survival (OS) According to PI3K Activation Pathway Status
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center St Joseph's
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group Dept of Highlands Oncology Grp
state: Arkansas
city: Morristown
country: United States
facility: Morristown Memorial Hospital MMH
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas HealthCare Systems Blumenthal Cancer Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center OU Health
state: Oklahoma
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI (2)
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology, P.A. Austin
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, PA South Tex Onc
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest CC Northwest- Spokane South(3)
state: Washington
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Le Mans Cedex
country: France
facility: Novartis Investigative Site
city: Lyon Cedex
country: France
facility: Novartis Investigative Site
city: Nice Cedex 2
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Bologna
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: