Status:
COMPLETED
A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose ...
Eligibility Criteria
Inclusion
- \[Single agent dose escalation arm\]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists.
- \[Combination part\]: Patients with metastatic HER2+ Breast Cancer, after failure of trastuzumab treatment. Eligible patients will have to have tumors carrying molecular alterations of PIK3CA and/or PTEN.
- \[Single agent safety expansion arm\]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. Patients will be prescreened for molecular alterations affecting PIK3CA and/or PTEN. Patients with NSCLC will also be pre-screened for EGFR mutation.
Exclusion
- Patients who have brain metastases, which are progressive and/or requiring medical intervention for symptom control
- Prior treatment with a PI3K inhibitor
- Acute or chronic liver disease or renal disease
- Acute or chronic pancreatitis
- Patients with unresolved diarrhea ≥ CTCAE grade 2
- Impaired cardiac function or clinically significant cardiac diseases
- Patients with diabetes mellitus requiring insulin treatment
- Patients with known coagulopathies
- Patients with a history of photosensitivity reactions to other drugs
- Any of the following ophthalmological findings:
- Progressive eye disease that could lead to severe loss of visual acuity or visual field
- loss during the study period
- Inability to perform the ophthalmic procedures required in this protocol
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 21 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2013
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT00620594
Start Date
December 21 2006
End Date
January 8 2013
Last Update
December 9 2020
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California at Los Angeles JonssonComprehensiveCancerCtr
Los Angeles, California, United States, 90095
2
Yale University School of Medicine YaleCancerCtr-ClinTrialsOffice
New Haven, Connecticut, United States, 06520
3
Dana Farber Cancer Institute Clinical Trials ProjectManager
Boston, Massachusetts, United States, 02215
4
Nevada Cancer Institute NVCC - Huntsman
Las Vegas, Nevada, United States, 89135