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Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer

NCT ID: NCT01602406

Last Updated: 2020-12-19

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-21

Study Completion Date

2017-08-02

Brief Summary

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This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of a dose escalation part and a dose expansion part. LJM716 will be administered intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing, administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be treated in successive cohorts. The dose escalation will continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to further assess the safety, tolerability, and anti-tumor activity of the combination.

Detailed Description

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Conditions

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Advanced HER2-positive Breast Cancer or Gastric Cancer

Keywords

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Advanced HER2-positive Breast cancer or Gastric cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LJM716 in combination with trastuzumab

Group Type EXPERIMENTAL

LJM716

Intervention Type DRUG

LJM716

Trastuzumab

Intervention Type DRUG

Trastuzumab

Interventions

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LJM716

LJM716

Intervention Type DRUG

Trastuzumab

Trastuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed HER-2 positive, metastatic or non-operable locally advanced breast or gastric cancer
* Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab, ado-trastuzumab emtansine or lapatinib
* Metastatic gastric cancer patients must have received a minimum of 1 and a maximum of 2 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab or ado-trastuzumab emtansine
* During the dose expansion part of study, all patients must have at least one measurable lesion as defined by RECIST criteria.
* Patients must have at least one prior trastuzumab-containing regimen
* Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

Exclusion Criteria

* Patients with Central Nervous System (CNS) metastasis which are: symptomatic or require treatment for symptom control and/or growing
* Prior treatment with any anti-HER3 (Human Epidermal growth factor Receptor 3) treatment
* Impaired cardiac function
* Prior to the first dose of study treatment, patients who have received systemic antineoplastic therapy or any investigational therapy within 4 weeks or within 5 half- lives of the therapy prior to starting study treatment, whichever is shorter, or for cyclical therapy, within one cycle length (e.g. 6 weeks for nitrosourea, mitomycin-C).
* Patients who have a history of primary malignancy other than that being treated in this study, and currently requires active clinical intervention.
* Patients who do not have an archival tumor sample (or sections of it) available or readily obtainable.
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

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Chapel Hill, North Carolina, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Wilrijk, , Belgium

Site Status

Novartis Investigative Site

Saint-Herblain, , France

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Valencia, Valencia, Spain

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Novartis Investigative Site

Oxford, , United Kingdom

Site Status

Countries

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United States Belgium France Italy Netherlands South Korea Spain Taiwan United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17162

Results for CLJM716X2102 from the Novartis Clinical Trials Website

Other Identifiers

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2011-004881-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLJM716X2102

Identifier Type: -

Identifier Source: org_study_id