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A Phase Ib Multi-center, Open-label, 4-arm Dose-escalation Study of Oral BEZ235 and BKM120 in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumors and Weekly Paclitaxel/Trastuzumab in Patients With HER2+ Metastatic Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic or Locally Advanced Solid Tumors,

Thank you

Trial Information

A Phase Ib Multi-center, Open-label, 4-arm Dose-escalation Study of Oral BEZ235 and BKM120 in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumors and Weekly Paclitaxel/Trastuzumab in Patients With HER2+ Metastatic Breast Cancer


Inclusion Criteria:



- Adult patients with metastatic or locally advanced solid tumors, for whom weekly
paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment)

- HER2+ metastatic or locally advanced breast cancer patients eligible for weekly
paclitaxel and trastuzumab (BEZ235-paclitaxel-trastuzumab
/BKM120-paclitaxel-trastuzumab treatment)

- Adult patients (≥ 18 years) (males, females)

- World Health Organization (WHO) performance status ≤ 2

- Adequate bone marrow function:

- Adequate hepatic and renal function:

Exclusion Criteria:

- Patients with primary central nervous system (CNS) tumor or CNS tumor involvement.
However, patients with a metastatic CNS lesion may participate in this trial, if the
patient is > 4 weeks from therapy (including radiation and/or surgery) completion,
clinically stable with respect to the tumor at the time of study entry, and not
receiving enzyme-inducing antiepileptic drugs or corticosteroid therapy or taper, as
treatment of the brain metastases

- Patients who have received prior systemic anticancer therapy within the following
time frames

- Cyclical chemotherapy: ≤ 3 weeks before study treatment (6 weeks for patients treated
with nitrosoureas)

- Biological therapy: ≤ 4 weeks before study treatment, except treatment with
trastuzumab (both parts of the trial)

- Investigational drug: ≤ 4 weeks before study treatment

- Patients who have undergone major surgery ≤ 4 weeks before study treatment

- Patients receiving chronic treatment with corticosteroids or other immunosuppressive
agents

- Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus

- Active or history of major depressive episode, bipolar disorder, obsessive-compulsive
disorder, schizophrenia, history of suicide attempt or ideation, or homicide, as
judged by the investigator and/or based on recent psychiatric assessment

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose limiting toxicities during the first cycle of treatment.

Outcome Time Frame:

First treatment cycle (4 weeks)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBEZ235A2118

NCT ID:

NCT01285466

Start Date:

January 2011

Completion Date:

November 2013

Related Keywords:

  • Metastatic or Locally Advanced Solid Tumors,
  • Cancer,
  • BEZ235,
  • BKM120,
  • paclitaxel,
  • trastuzumab

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