Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01289041
Ethics application status
Date submitted
26/01/2011
Date registered
2/02/2011
Date last updated
30/03/2015

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 - 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)
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
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. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.
Timepoint [2] 0 0
every 3 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
Gender
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
Non-randomised trial
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
Blinded (masking 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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