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A Phase I/II, Multi-center, Open-label Study of BEZ235, Administered Orally on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer,, Advanced Solid Tumors,, Cowden Syndrome

Thank you

Trial Information

A Phase I/II, Multi-center, Open-label Study of BEZ235, Administered Orally on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer


Inclusion Criteria:



[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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine the maximum Tolerated Dose (MTD) of BEZ235 as single agent and in combination with trastuzumab (Dose escalation part)

Outcome Time Frame:

at end of study

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBEZ235A2101

NCT ID:

NCT00620594

Start Date:

December 2006

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer,
  • Advanced Solid Tumors,
  • Cowden Syndrome
  • Neoplasms,
  • breast neoplasms,
  • breast diseases,
  • solid tumors,
  • BEZ235,
  • breast cancer,
  • PI3K Inhibitor,
  • Phosphatidylinositol 3',
  • kinase,
  • advanced
  • Breast Neoplasms
  • Hamartoma Syndrome, Multiple

Name

Location

Cancer Centers of the Carolinas CCC FarisGreenville, South Carolina  29605
MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med.Onc(2)Houston, Texas  77030-4009
University of California at Los Angeles JonssonComprehensiveCancerCtrLos Angeles, California  90095
Yale University School of Medicine YaleCancerCtr-ClinTrialsOfficeNew Haven, Connecticut  06520
Dana Farber Cancer Institute Clinical Trials ProjectManagerBoston, Massachusetts  02115
Nevada Cancer Institute NVCC - HuntsmanLas Vegas, Nevada  89135
Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(2)Nashville, Tennessee  37203
Baylor College of Medicine Baylor- SammonsDallas, Texas  75246
Tyler Cancer Center TCCTyler, Texas  75702