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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Novartis
• Treatments: Dactolisib; Everolimus; Sirolimus

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)