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BKM120 as Second-line Therapy for Advanced Endometrial Cancer

Primary Purpose

Advanced Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BKM120
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Endometrial Cancer focused on measuring Advanced endometrial cancer, PI3K pathway, second-line treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital & Medical Center St Joseph's
  • Highlands Oncology Group Dept of Highlands Oncology Grp
  • Morristown Memorial Hospital MMH
  • Carolinas HealthCare Systems Blumenthal Cancer Center
  • University of Oklahoma Health Sciences Center OU Health
  • Sarah Cannon Research Institute SCRI (2)
  • Texas Oncology, P.A. Austin
  • South Texas Oncology and Hematology, PA South Tex Onc
  • Cancer Care Northwest CC Northwest- Spokane South(3)
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 26, 2011
Last Updated
May 20, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01289041
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Endometrial Cancer
Keywords
Advanced endometrial cancer, PI3K pathway, second-line treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BKM120
Other Intervention Name(s)
Buparlisib
Primary Outcome Measure Information:
Title
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) According to PI3K Activation Pathway Status
Description
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.
Time Frame
24 months
Title
Overall Survival (OS) According to PI3K Activation Pathway Status
Description
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
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital & Medical Center St Joseph's
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Highlands Oncology Group Dept of Highlands Oncology Grp
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Morristown Memorial Hospital MMH
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Carolinas HealthCare Systems Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
University of Oklahoma Health Sciences Center OU Health
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Sarah Cannon Research Institute SCRI (2)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology, P.A. Austin
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
South Texas Oncology and Hematology, PA South Tex Onc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Cancer Care Northwest CC Northwest- Spokane South(3)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20220410
Country
Brazil
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Novartis Investigative Site
City
Le Mans Cedex
ZIP/Postal Code
72015
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex
ZIP/Postal Code
69373
Country
France
Facility Name
Novartis Investigative Site
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Novartis Investigative Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Novartis Investigative Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
00973
Country
Poland
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46009
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

BKM120 as Second-line Therapy for Advanced Endometrial Cancer

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