Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | January 2012 |
| End Date: | April 2015 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
A Dose-finding Phase Ib Study Followed by an Open-label, Randomized Phase II Study of BEZ235 Plus Paclitaxel in Patients With HER2 Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with
patients that have locally advanced or metastatic HER2 negative breast cancer. The first
part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the
combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian
model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will
evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly
paclitaxel plus BEZ235 bid.
patients that have locally advanced or metastatic HER2 negative breast cancer. The first
part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the
combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian
model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will
evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly
paclitaxel plus BEZ235 bid.
Inclusion Criteria (phase lb):
- Females with Breast cancer that is histologically or cytologically confirmed, HER2
negative and locally advanced or metastatic as confirmed by radiology
- ECOG performance status 0 and 1
- Adequate bone marrow and organ function
Exclusion Criteria (Phase lb):
- Previous treatment with PI3K and/or mTOR inhibitors
- Symptomatic Central Nervous System (CNS) metastases
- Concurrent malignancy or malignancy in the last 5 years prior to start of study
treatment
- Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days
prior to starting study drug
- Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF
> 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal
arrhythmias)
- Inadequately controlled hypertension
- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of BEZ235 and/or paclitaxel
- Treatment at start of study treatment with drugs with a known risk to induce Torsades
de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin
and coumadin analogues, LHRH agonists
- Sensitivity to paclitaxel treatment
- Uncontrolled diabetes mellitus
- Pregnant or nursing (lactating) woman
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
4
sites
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