Clinical trial · Interventional
A Study of BKM120 in Adult Japanese Patients With Advanced Solid Tumors
A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
NCT01283503CI-TRIAL-00048711completedPhase 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)
In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.
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 Solid Tumor | Solid 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
- BKM120
- interventionNames
- Drug: BKM120
Primary outcomes (1)
- measure
- establish Maximum tolerate dose (MTD)
- timeFrame
- every day up to first 4 weeks
Secondary outcomes (4)
- measure
- Safety assessed by type, frequency and severity of adverse events
- timeFrame
- Every week
- measure
- Efficacy assessed by RECIST
- timeFrame
- Every 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists. 2. At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors. 3. Age ≥ 20 years 4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2 5. Life expectancy of ≥ 12 weeks 6. Patients must have the laboratory values Exclusion Criteria: 1. Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases 2. Prior treatment with a PI3K inhibitor 3. Patients with any peripheral neuropathy ≥ CTCAE grade 2 4. Patients with unresolved diarrhea ≥ CTCAE grade 2 5. Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.