BKM120 as Second-line Therapy for Advanced Endometrial Cancer

Advanced Endometrial Cancer Clinical Trial

Official title:

A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289041
• Other study ID #: CBKM120C2201
• Secondary ID: 2010-022015-19
• Status: Completed
• Phase: Phase 2
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: May 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• BKM120

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Parkville	Victoria
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Wilrijk
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
France	Novartis Investigative Site	Le Mans Cedex
France	Novartis Investigative Site	Lyon Cedex
France	Novartis Investigative Site	Nice Cedex 2
France	Novartis Investigative Site	Toulouse Cedex 9
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Mainz
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma	RM
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Nagoya	Aichi
Poland	Novartis Investigative Site	Warszawa
Russian Federation	Novartis Investigative Site	St. Petersburg
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
United States	Texas Oncology, P.A. Austin	Bedford	Texas
United States	Carolinas HealthCare Systems Blumenthal Cancer Center	Charlotte	North Carolina
United States	Highlands Oncology Group Dept of Highlands Oncology Grp	Fayetteville	Arkansas
United States	Morristown Memorial Hospital MMH	Morristown	New Jersey
United States	Sarah Cannon Research Institute SCRI (2)	Nashville	Tennessee
United States	University of Oklahoma Health Sciences Center OU Health	Oklahoma City	Oklahoma
United States	St. Joseph's Hospital & Medical Center St Joseph's	Phoenix	Arizona
United States	South Texas Oncology and Hematology, PA South Tex Onc	San Antonio	Texas
United States	Cancer Care Northwest CC Northwest- Spokane South(3)	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  France,  Germany,  Italy,  Japan,  Poland,  Russian Federation,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status	BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR	24 months
Secondary	Progression Free Survival (PFS) According to PI3K Activation Pathway Status	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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	24 months
Secondary	Overall Survival (OS) According to PI3K Activation Pathway Status	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. 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	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