Clinical trial · Interventional
Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients
A Phase IA, Multicenter, Open-label Dose Escalation Study of BKM120, Administered Orally in Adult Patients With Advanced Solid Malignancies
NCT01068483CI-TRIAL-00048687completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part. Once the MTD has been defined, the MTD expansion part will be opened for enrollment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Endometrium Cancer | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BKM120 | Drug | Buparlisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BKM120
- description
- Dose escalation followed by dose expansion
- interventionNames
- Drug: BKM120
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of BKM120
- timeFrame
- throughout the study
Secondary outcomes (5)
- measure
- Safety and tolerability of BKM120
- timeFrame
- throughout the study
- measure
- Pharmacokinetics of BKM120
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All patients: * Histologically-confirmed advanced solid tumors * Progressive, recurrent unresectable disease * World Health Organization (WHO) Performance status ≤ 2 * No history of primary brain tumor or brain metastases MTD Expansion part: * Histologically-confirmed advanced solid tumors * Progressive, recurrent unresectable disease * World Health Organization (WHO) Performance status ≤ 2 * No history of primary brain tumor; no brain metastases unless asymptomatic and clinically stable for ≥ 3 months * Patients with genetic or molecular alteration of the PI3K pathway Exclusion Criteria: * Prior treatment with a PI3K inhibitor * History of or active major depressive episode, bipolar disorder, schizophrenia, or history of suicidal attempt or ideation * No clinically manifest diabetes mellitus (treated and/or with clinical signs) * No acute or chronic renal disease * No acute or chronic liver disease * No acute or chronic pancreatitis * No unresolved diarrhea * No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension * No acute myocardial infarction or unstable angina pectoris within the past 3 months * Not pregnant or nursing and fertile patients must use barrier contraceptives Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.