Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors
This study is currently recruiting participants.
Verified January 2012 by University of Cincinnati
Sponsor:
University of Cincinnati
Collaborator:
Novartis
Information provided by (Responsible Party):
Oliver Rixe, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01508104
First received: January 6, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: BEZ235 Drug: Everolimus |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- Dose limiting toxicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 54 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BEZ235 and Everolimus |
Drug: BEZ235
dose escalation 400mg- 1000mg per day
Other Name: BEZ235
Drug: Everolimus
dose escalation 2.5 to 5 mg per day
Other Name: RAD001
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508104
Contacts
| Contact: UC Cancer Institute | 513-584-7698 | |
| Contact: UC Cancer Institute |
Locations
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267-0502 | |
| Contact: UC Cancer Institute 513-584-7698 | |
| Principal Investigator: Olivier Rixe, MD, PhD | |
Sponsors and Collaborators
University of Cincinnati
Novartis
Investigators
| Principal Investigator: | Olivier Rixe, MD, PhD | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | Oliver Rixe, Professor of Medicine, Director of Experimental Therapeutics Program, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01508104 History of Changes |
| Other Study ID Numbers: | CBEZ235ZUS08T |
| Study First Received: | January 6, 2012 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Cincinnati:
|
solid tumor glioblastoma multiforme GBM brain tumor neuroendocrine tumor |
Additional relevant MeSH terms:
|
Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013