- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01508104
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
Study Overview
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 the other is called PI3K.
Everolimus is an agent that also targets mTOR thus also slows down cell growth and spread; in addition, it injures blood vessels that supply cancer cells with nutrition.
The rationale behind combining Everolimus with BEZ235 is to inhibit cell growth and halt cancer spread by greater degree than either drug alone.
BEZ235 is not approved by the FDA for use in humans outside the context of a clinical trial.
Everolimus is FDA approved for the treatment of renal cell carcinoma (kidney cancer), subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), and Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45267-0502
- University of Cincinnati
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BEZ235 and Everolimus
|
dose escalation 400mg- 1000mg per day
dose escalation 2.5 to 5 mg per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicity
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John Morris, MD, University of Cincinnati
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBEZ235ZUS08T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Novartis PharmaceuticalsCompleted
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