Clinical trial · Interventional
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
A Phase Ib Multi-center, Open-label, 4-arm Dose-escalation Study of Oral BEZ235 and BKM120 in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumors and Weekly Paclitaxel/Trastuzumab in Patients With HER2+ Metastatic Breast Cancer
NCT01285466CI-TRIAL-00048761completedPhase 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)
The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.
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 |
|---|---|---|---|
| Metastatic or Locally Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEZ235 + paclitaxel | Drug | — | UNRESOLVED |
| BEZ235 + paclitaxel + trastuzumab | Drug | — | UNRESOLVED |
| BKM120 + paclitaxel | Drug | — | UNRESOLVED |
| BKM120 + paclitaxel + trastuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- BEZ235 + paclitaxel
- interventionNames
- Drug: BEZ235 + paclitaxel
- type
- EXPERIMENTAL
- label
- BKM120 + paclitaxel
- interventionNames
- Drug: BKM120 + paclitaxel
- type
- EXPERIMENTAL
- label
- BEZ235 + paclitaxel + trastuzumab
- interventionNames
- Drug: BEZ235 + paclitaxel + trastuzumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment) * HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ235-paclitaxel-trastuzumab /BKM120-paclitaxel-trastuzumab treatment) * Adult patients (≥ 18 years) (males, females) * World Health Organization (WHO) performance status ≤ 2 * Adequate bone marrow function: * Adequate hepatic and renal function: Exclusion Criteria: * Patients with primary central nervous system (CNS) tumor or CNS tumor involvement. However, patients with a metastatic CNS lesion may participate in this trial, if the patient is \> 4 weeks from therapy (including radiation and/or surgery) completion, clinically stable with respect to the tumor at the time of study entry, and not receiving enzyme-inducing antiepileptic drugs or corticosteroid therapy or taper, as treatment of the brain metastases * Patients who have received prior systemic anticancer therapy within the following time frames * Cyclical chemotherapy: ≤ 3 weeks before study treatment (6 weeks for patients treated with nitrosoureas) * Biological therapy: ≤ 4 weeks before study treatment, except treatment with trastuzumab (both parts of the trial) * Investigational drug: ≤ 4 weeks before study treatment * Patients who have undergone major surgery ≤ 4 weeks before study treatment * Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents * Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus * Active or history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicide attempt or ideation, or homicide, as judged by the investigator and/or based on recent psychiatric assessment Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.