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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911936
• Other study ID #: CLJM716X1101
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 escalation part and a dose expansion part.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• LM716

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Koto	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs) in the dose escalation part		First cycle (28 days)
Secondary	Frequency and severity of adverse events, number of and reasons for		from informed consent till 30 days after end of treatment
Secondary	LJM716 serum concentration-time- profile and estimated PK		up to 10 cycle (1 cycle = 28 days)
Secondary	Tumor response according to RECIST 1.1		every 2 months until end of treatment up to 2 years
Secondary	Incidence of antibodies against LJM716		up to 10 cycle ( 1cycle = 28 days)

External Links

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