A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285466
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

January 26, 2011
January 28, 2011
February 14, 2017
January 2011
October 2014   (Final data collection date for primary outcome measure)
Incidence of Dose limiting toxicities during the first cycle of treatment. [ Time Frame: First treatment cycle (4 weeks) ]
Same as current
Complete list of historical versions of study NCT01285466 on Archive Site
  • Incidence of safety events during the whole treatment period (until progression of disease). [ Time Frame: From start of treatment until disease progression ]
  • pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22. [ Time Frame: First treatment cycle (4 weeks) ]
  • Treatment efficacy (response to treatment according to RECIST criteria) [ Time Frame: From start of treatment until disease progression ]
  • Impact of treatment on biomarkers of Pi3 Kinase pathway (analyses of skin biopsies, circulating markers) [ Time Frame: From start of treatment until disease progression ]
Same as current
Not Provided
Not Provided
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
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
The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic or Locally Advanced Solid Tumors
  • Drug: BEZ235 + paclitaxel
  • Drug: BKM120 + paclitaxel
  • Drug: BEZ235 + paclitaxel + trastuzumab
  • Drug: BKM120 + paclitaxel + trastuzumab
  • Experimental: BEZ235 + paclitaxel
    Intervention: Drug: BEZ235 + paclitaxel
  • Experimental: BKM120 + paclitaxel
    Intervention: Drug: BKM120 + paclitaxel
  • Experimental: BEZ235 + paclitaxel + trastuzumab
    Intervention: Drug: BEZ235 + paclitaxel + trastuzumab
  • Experimental: BKM120 + paclitaxel + trastuzumab
    Intervention: Drug: BKM120 + paclitaxel + trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2014
October 2014   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Netherlands,   Spain,   Switzerland
2010-022331-11 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP