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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00620594 |
This is a first-in-man, phase I/II clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a
Phase I dose escalation part followed by a safety expansion part and a Phase II expansion part:
Phase I dose escalation part (advanced solid tumors):
Patients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of at least 3 patients receive escalating doses of BEZ235 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose expected to produce during the first course of treatment dose-limiting toxicity in 33% of patients.
Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial will be opened for enrollment.
Phase I safety expansion part (advanced solid tumors):
Patients will be treated with BEZ235, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects.
Phase II expansion part (advanced breast cancer):
Patients will be treated with BEZ235, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects. An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies.
Condition | Intervention | Phase |
---|---|---|
Solid Tumors Breast Cancer |
Drug: BEZ235A |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Disease Characteristics:
All patients
Phase II expansion part (advanced breast cancer)
Cowden Syndrome patients with an advanced malignancy
Patient Characteristics:
Prior/Concurrent Therapy:
Contact: Novartis | 862 778 8300 |
United States, Tennessee | |
Sarah Cannon Research Institute | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Howard Burris, M.D. 615-329-7224 |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CBEZ235A2101 |
Study First Received: | February 8, 2008 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00620594 History of Changes |
Health Authority: | United States: Food and Drug Administration |
BEZ235A Solid tumors Breast cancer Cowden Syndrome |
Phosphatidylinositol 3'-kinase (PI3K) inhibitor Advanced solid tumors (sporadic and Cowden Syndrome) (Phase I part) Advanced breast cancer (sporadic and Cowden Syndrome) (Phase II part) |
Hamartoma Syndrome, Multiple Skin Diseases Breast Neoplasms Cowden's Disease Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |