A Phase 2 interventional study of BKM120 in Advanced Endometrial Cancer, sponsored by Novartis Pharmaceuticals. Completed at 42 sites in 13 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: BKM120
Also known as: Buparlisib
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. 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
Time frame: 24 months
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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 24 months
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. 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
Time frame: 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
| Milestone | All Patients |
|---|---|
| Started | 70 |
| Completed | 0 |
| Not completed | 70 |
| Withdrew: Adverse event | 24 |
| Withdrew: Physician decision | 1 |
| Withdrew: Progressive disease | 41 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Death | 1 |
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
| number of participants | Activated Pl3K | Non-Activated Pl3K | All Patients |
|---|---|---|---|
| Patients with Measurable disease at baseline | 49 | 21 | 70 |
| Complete Response (CR) | 1 | 0 | 1 |
| Partial Response (PR) | 0 | 1 | 1 |
| Stable Disease (SD) | 19 | 7 | 26 |
| Progressive disease (PD) | 20 | 9 | 29 |
| Unknown (UNK) | 9 | 4 | 13 |
| Overall Response Rate (CR + PR) | 1 | 1 | 2 |
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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| months | Activated Pl3K | Non-Activated Pl3K | All Patients |
|---|---|---|---|
| Progression Free Survival (PFS) According to PI3K Activation Pathway Status | 1.9 (1.8 to 3.2) | 1.9 (1.6 to 3.3) | 1.9 (1.8 to 2.8) |
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. 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
| months | Activated Pl3K | Non-Activated Pl3K | All Patients |
|---|---|---|---|
| Overall Survival (OS) According to PI3K Activation Pathway Status | 8.9 (6.3 to 16.2) | 14.2 (8.6 to 24.0) | 9.9 (7.4 to 16.2) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | — | 33/70 (47.1%) | 67/70 (95.7%) |
| Event | All Patients |
|---|---|
| DehydrationMetabolism and nutrition disorders | 4/70 |
| HyperglycaemiaMetabolism and nutrition disorders | 4/70 |
| VomitingGastrointestinal disorders | 3/70 |
| HypersensitivityImmune system disorders | 3/70 |
| HydronephrosisRenal and urinary disorders | 3/70 |
| Abdominal painGastrointestinal disorders | 2/70 |
| NauseaGastrointestinal disorders | 2/70 |
| StomatitisGastrointestinal disorders | 2/70 |
| AstheniaGeneral disorders | 2/70 |
| SepsisInfections and infestations | 2/70 |
| Event | All Patients |
|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 37/70 |
| NauseaGastrointestinal disorders | 31/70 |
| Decreased appetiteMetabolism and nutrition disorders | 28/70 |
| FatigueGeneral disorders | 24/70 |
| RashSkin and subcutaneous tissue disorders | 21/70 |
| Aspartate aminotransferase increasedInvestigations | 18/70 |
| DiarrhoeaGastrointestinal disorders | 17/70 |
| Alanine aminotransferase increasedInvestigations | 17/70 |
| AnxietyPsychiatric disorders | 17/70 |
| DepressionPsychiatric disorders | 16/70 |
| Age, Continuous(years) | All Patients |
|---|---|
| Mean | 63 ± 9.04 |
| Sex/Gender, Customized(participants) | All Patients |
|---|---|
| Female | 70 |
| Male | 0 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals