Clinical trial · Interventional
Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors
A Dose Escalation, Single Arm, Phase 1b-2 Combination Study of BEZ235 With Everolimus to Determine the Safety, Pharmacodynamics and Pharmacokinetics in Subjects With Advanced Solid Malignancies
NCT01508104CI-TRIAL-00029221terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding
Summary
Brief summary (as posted)
The purpose of this clinical trial is to determine the effects good or bad of combining BEZ235 along with Everolimus to determine if it is a safe treatment for patients with advanced cancers of different types.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEZ235 | Drug | Dactolisib | ALIAS |
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BEZ235 and Everolimus
- interventionNames
- Drug: BEZ235
- Drug: Everolimus
Primary outcomes (1)
- measure
- Dose limiting toxicity
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable, and for which standard/curative measures do not exist by RECIST 1.1 measureable lesion which is not declining * Age ≥ 18 years old at the day of consenting to the study * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Adequate bone marrow and organ function as defined by laboratory values Exclusion Criteria: * Previous treatment with PI3K inhibitors * Concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ) * Concurrently using other approved or investigational antineoplastic agent * Currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, hormonal therapy, etc.) * Poorly controlled diabetes mellitus (HbA1c \> 8 %) * Chronic treatment with systemic steroids or another immunosuppressive agent * Active cardiac disease * Inadequately controlled hypertension (i.e, SBP \>180 mmHg or DBP \>100mmHg) * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea grade ≥ 2, malabsorption syndrome, or small bowel resection)
References
Publications (1)
- DERIVEDWise-Draper TM, Moorthy G, Salkeni MA, Karim NA, Thomas HE, Mercer CA, Beg MS, O'Gara S, Olowokure O, Fathallah H, Kozma SC, Thomas G, Rixe O, Desai P, Morris JC. A Phase Ib Study of the Dual PI3K/mTOR Inhibitor Dactolisib (BEZ235) Combined with Everolimus in Patients with Advanced Solid Malignancies. Target Oncol. 2017 Jun;12(3):323-332. doi: 10.1007/s11523-017-0482-9. PMID 28357727