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A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

NCT ID: NCT01911936

Last Updated: 2020-12-17

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-03-31

Brief Summary

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This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

Detailed Description

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This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

Conditions

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Neoplasms

Keywords

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CLJM716, Japanese patients, Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LJM716

Group Type EXPERIMENTAL

LM716

Intervention Type DRUG

Interventions

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LM716

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with the following indications:

i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
* For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
* For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
2. ECOG Performance Status of 0-2
3. Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
4. Willingness and ability to comply with all study procedures
5. Written informed consent obtained prior to any screening procedures
6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
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

Koto, Tokyo, Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Countries

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Japan

References

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Takahashi S, Kobayashi T, Tomomatsu J, Ito Y, Oda H, Kajitani T, Kakizume T, Tajima T, Takeuchi H, Maacke H, Esaki T. LJM716 in Japanese patients with head and neck squamous cell carcinoma or HER2-overexpressing breast or gastric cancer. Cancer Chemother Pharmacol. 2017 Jan;79(1):131-138. doi: 10.1007/s00280-016-3214-4. Epub 2016 Dec 9.

Reference Type DERIVED
PMID: 27942917 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14468

Results for CLJM716X1101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLJM716X1101

Identifier Type: -

Identifier Source: org_study_id