Phase 2
N=70
BKM120 as Second-line Therapy for Advanced Endometrial Cancer
Advanced Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01289041 ↗Enrolled (actual)
70
Serious AEs
47.1%
Results posted
Apr 2015
Primary outcome: Primary: Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status — 49; 21; 70; 1 number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BKM120 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status |
49; 21; 70; 1; 0; 1 | — |
| SECONDARY Progression Free Survival (PFS) According to PI3K Activation Pathway Status |
1.9; 1.9; 1.9 | — |
| SECONDARY Overall Survival (OS) According to PI3K Activation Pathway Status |
8.9; 14.2; 9.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01289041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.