Clinical trial · Interventional
Bevacizumab and BKM-120 in Patients With Metastatic Renal Cell Carcinoma
A Phase I Study of Bevacizumab and Escalation Doses of BKM-120 in Patients With Metastatic Renal Cell Carcinoma Who Failed Prior Systemic Therapies
- 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)
BKM-120 is a drug that may slow the growth of cancer cells. This drug has been used in laboratory experiments and information from those research studies suggests that this drug may help to slow the growth of renal cancer cells. In this research study, the investigators are testing the safety to BKM-120 at different dose levels. The investigators will also be studying how well tolerated BKM-120 is, and how effective BKM-120 can be in the treatment of kidney cancer.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BKM-120 Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BKM-120 Bevacizumab
- description
- BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
- interventionNames
- Drug: BKM-120 Bevacizumab
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose and dose limiting toxicities of the combination of BKM-120 and bevacizumab in metastatic renal cell carcinoma
- timeFrame
- 2 year
Secondary outcomes (3)
- measure
- To determine additional toxicity and safety information from the combination of BKM-120 and bevacizumab in an expanded cohort of patients at the MTD
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic RCC with clear cell component or papillary RCC * Life expectancy \> 12 weeks * Must have failed at least 1 prior anti-VEGF systemic therapy for metastatic RCC Exclusion Criteria: * Prior treatment with a P13K inhibitor or bevacizumab * Untreated brain metastases * Acute or chronic liver or pancreatic disease * Major mood disorder * Concurrent severe and/or uncontrolled medical condition * Diabetes mellitus * GI disease * Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant * Pregnant or breastfeeding * HIV positive * History of another malignancy within 3 years except cured basal cell carcinoma of the skin or excised in situ carcinoma of the cervix * Uncontrolled hypertension
References
Publications (0)
Data not yet available