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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01289041




Registration number
NCT01289041
Ethics application status
Date submitted
26/01/2011
Date registered
3/02/2011
Date last updated
30/05/2019

Titles & IDs
Public title
BKM120 as Second-line Therapy for Advanced Endometrial Cancer
Scientific title
A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
Secondary ID [1] 0 0
2010-022015-19
Secondary ID [2] 0 0
CBKM120C2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BKM120

Experimental: All Patients -


Treatment: Drugs: BKM120
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS) According to PI3K Activation Pathway Status
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Overall Survival (OS) According to PI3K Activation Pathway Status
Timepoint [2] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Oklahoma
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Belgium
State/province [10] 0 0
Liege
Country [11] 0 0
Belgium
State/province [11] 0 0
Wilrijk
Country [12] 0 0
Brazil
State/province [12] 0 0
RJ
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
Le Mans Cedex
Country [17] 0 0
France
State/province [17] 0 0
Lyon Cedex
Country [18] 0 0
France
State/province [18] 0 0
Nice Cedex 2
Country [19] 0 0
France
State/province [19] 0 0
Toulouse Cedex 9
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Köln
Country [22] 0 0
Germany
State/province [22] 0 0
Mainz
Country [23] 0 0
Italy
State/province [23] 0 0
MI
Country [24] 0 0
Italy
State/province [24] 0 0
PN
Country [25] 0 0
Italy
State/province [25] 0 0
RM
Country [26] 0 0
Italy
State/province [26] 0 0
Bologna
Country [27] 0 0
Italy
State/province [27] 0 0
Napoli
Country [28] 0 0
Japan
State/province [28] 0 0
Aichi
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Russian Federation
State/province [31] 0 0
St. Petersburg
Country [32] 0 0
Singapore
State/province [32] 0 0
Singapore
Country [33] 0 0
Spain
State/province [33] 0 0
Catalunya
Country [34] 0 0
Spain
State/province [34] 0 0
Comunidad Valenciana
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01289041
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01289041