BKM120 as Second-line Therapy for Advanced Endometrial Cancer
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: January 26, 2011
Last updated: March 30, 2015
Last verified: March 2015
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.
Advanced Endometrial Cancer
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
Primary Outcome Measures:
- Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status [ Time Frame: 24 months ]
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)
Secondary Outcome Measures:
- Progression Free Survival (PFS) According to PI3K Activation Pathway Status [ Time Frame: 24 months ]
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.
- Overall Survival (OS) According to PI3K Activation Pathway Status [ Time Frame: every 3 months ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Experimental: All Patients
Other Name: Buparlisib
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01289041
History of Changes
|Other Study ID Numbers:
2010-022015-19 ( EudraCT Number )
|Study First Received:
||January 26, 2011
|Results First Received:
||March 30, 2015
||March 30, 2015
Keywords provided by Novartis:
Advanced endometrial cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 23, 2017
Genital Neoplasms, Female
Neoplasms by Site
Genital Diseases, Female