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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by University of Cincinnati
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014