Status:
COMPLETED
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.
Detailed Description
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 escala...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01911936
Start Date
September 1 2013
End Date
March 1 2015
Last Update
December 17 2020
Active Locations (2)
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1
Novartis Investigative Site
Koto, Tokyo, Japan, 135-8550
2
Novartis Investigative Site
Fukuoka, Japan, 811-1395