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

NCT ID: NCT01285466

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic or Locally Advanced Solid Tumors

Keywords

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Cancer BEZ235 BKM120 paclitaxel trastuzumab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BEZ235 + paclitaxel

Group Type EXPERIMENTAL

BEZ235 + paclitaxel

Intervention Type DRUG

BKM120 + paclitaxel

Group Type EXPERIMENTAL

BKM120 + paclitaxel

Intervention Type DRUG

BEZ235 + paclitaxel + trastuzumab

Group Type EXPERIMENTAL

BEZ235 + paclitaxel + trastuzumab

Intervention Type DRUG

BKM120 + paclitaxel + trastuzumab

Group Type EXPERIMENTAL

BKM120 + paclitaxel + trastuzumab

Intervention Type DRUG

Interventions

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BEZ235 + paclitaxel

Intervention Type DRUG

BKM120 + paclitaxel

Intervention Type DRUG

BEZ235 + paclitaxel + trastuzumab

Intervention Type DRUG

BKM120 + paclitaxel + trastuzumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Wilrijk, , Belgium

Site Status

Novartis Investigative Site

Cologne, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Chur, , Switzerland

Site Status

Novartis Investigative Site

Sankt Gallen, , Switzerland

Site Status

Countries

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Belgium Germany Netherlands Spain Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14187

Results for CBEZ235A2118 can be found on the Novartis Clinical Trials website

Other Identifiers

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2010-022331-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBEZ235A2118

Identifier Type: -

Identifier Source: org_study_id