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

Stopped early · Phase 1

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT01508104

Run by

University of Cincinnati

People needed

19

Starts

2012-01-01

Expected to finish

2014-12-01

Last updated by the study team

2017-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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