Clinical trial · Interventional
BKM120 as Second-line Therapy for Advanced Endometrial Cancer
A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BKM120 | Drug | Buparlisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Patients
- interventionNames
- Drug: BKM120
Primary outcomes (1)
- measure
- Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status
- timeFrame
- 24 months
- 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
Secondary outcomes (2)
- measure
- Progression Free Survival (PFS) According to PI3K Activation Pathway Status
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available