Status:
TERMINATED
Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Novartis
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 differ...
Detailed Description
BEZ235 is an agent that was developed to slow down or halt cell growth and proliferation. It works by inhibiting two pathways that are important for cell growth and replication, one is called mTOR and...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01508104
Start Date
January 1 2012
End Date
December 1 2014
Last Update
August 23 2017
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0502