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Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01508104
Recruitment Status : Terminated (funding)
First Posted : January 11, 2012
Last Update Posted : August 23, 2017
Information provided by (Responsible Party):
John Morris, University of Cincinnati

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 different types.

Condition or disease Intervention/treatment Phase
Cancer Drug: BEZ235 Drug: Everolimus Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Experimental: BEZ235 and Everolimus Drug: BEZ235
dose escalation 400mg- 1000mg per day

Drug: Everolimus
dose escalation 2.5 to 5 mg per day
Other Name: RAD001

Primary Outcome Measures :
  1. Dose limiting toxicity [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01508104

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0502
Sponsors and Collaborators
University of Cincinnati
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Principal Investigator: John Morris, MD University of Cincinnati
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: John Morris, Professor, University of Cincinnati Identifier: NCT01508104    
Other Study ID Numbers: CBEZ235ZUS08T
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Keywords provided by John Morris, University of Cincinnati:
solid tumor
glioblastoma multiforme
brain tumor
neuroendocrine tumor
Additional relevant MeSH terms:
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Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs