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

December 6, 2020 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1000
        • Novartis Investigative Site
      • Wilrijk, Belgium, 2610
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Köln, Germany, 50937
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Novartis Investigative Site
  • Spain
    • Andalucia
      • Sevilla, Andalucia, Spain, 41013
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
  • Switzerland
      • Chur, Switzerland, 7000
        • Novartis Investigative Site
      • St. Gallen, Switzerland, 9007
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BEZ235 + paclitaxel
Drug: BEZ235 + paclitaxel
EXPERIMENTAL: BKM120 + paclitaxel
Drug: BKM120 + paclitaxel
EXPERIMENTAL: BEZ235 + paclitaxel + trastuzumab
Drug: BEZ235 + paclitaxel + trastuzumab
EXPERIMENTAL: BKM120 + paclitaxel + trastuzumab
Drug: BKM120 + paclitaxel + trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Dose limiting toxicities during the first cycle of treatment.
Time Frame: First treatment cycle (4 weeks)
First treatment cycle (4 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of safety events during the whole treatment period (until progression of disease).
Time Frame: From start of treatment until disease progression
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)
First treatment cycle (4 weeks)
Treatment efficacy (response to treatment according to RECIST criteria)
Time Frame: From start of treatment until disease progression
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
From start of treatment until disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (ESTIMATE)

January 28, 2011

Study Record Updates

Last Update Posted (ACTUAL)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBEZ235A2118
  • 2010-022331-11 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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