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Completed

NCT Number: NCT01911936

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

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

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Koto, Tokyo, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • ECOG Performance Status of 0-2
  • 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.
  • Willingness and ability to comply with all study procedures
  • Written informed consent obtained prior to any screening procedures
  • During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria

Treatment and study plan

LM716

Drug

Primary outcomes

  1. Incidence of dose-limiting toxicities (DLTs) in the dose escalation part

    Time frame: First cycle (28 days)

Secondary outcomes

  1. Frequency and severity of adverse events, number of and reasons for

    Time frame: from informed consent till 30 days after end of treatment

  2. LJM716 serum concentration-time- profile and estimated PK

    Time frame: up to 10 cycle (1 cycle = 28 days)

  3. Tumor response according to RECIST 1.1

    Time frame: every 2 months until end of treatment up to 2 years

  4. Incidence of antibodies against LJM716

    Time frame: up to 10 cycle ( 1cycle = 28 days)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2013
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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