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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.
 
ClinicalTrials.gov Identifier: NCT01508104
Recruitment Status : Terminated (funding)
First Posted : January 11, 2012
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
John Morris, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE January 6, 2012
First Posted Date  ICMJE January 11, 2012
Last Update Posted Date August 23, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2012)
Dose limiting toxicity [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: BEZ235
    dose escalation 400mg- 1000mg per day
  • Drug: Everolimus
    dose escalation 2.5 to 5 mg per day
    Other Name: RAD001
Study Arms  ICMJE Experimental: BEZ235 and Everolimus
Interventions:
  • Drug: BEZ235
  • Drug: Everolimus
Publications * Wise-Draper TM, Moorthy G, Salkeni MA, Karim NA, Thomas HE, Mercer CA, Beg MS, O'Gara S, Olowokure O, Fathallah H, Kozma SC, Thomas G, Rixe O, Desai P, Morris JC. A Phase Ib Study of the Dual PI3K/mTOR Inhibitor Dactolisib (BEZ235) Combined with Everolimus in Patients with Advanced Solid Malignancies. Target Oncol. 2017 Jun;12(3):323-332. doi: 10.1007/s11523-017-0482-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 21, 2017)
19
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2012)
54
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508104
Other Study ID Numbers  ICMJE CBEZ235ZUS08T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Morris, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: John Morris, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP