Clinical trial NCT01911936: A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
Official title: A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: CLJM716,
Japanese patients,
Neoplasms
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 escalation part and a dose expansion part.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
timeFrame: First cycle (28 days)
Secondary outcomes:
measure: Frequency and severity of adverse events, number of and reasons for
timeFrame: from informed consent till 30 days after end of treatment
measure: LJM716 serum concentration-time- profile and estimated PK
timeFrame: up to 10 cycle (1 cycle = 28 days)
measure: Tumor response according to RECIST 1.1
timeFrame: every 2 months until end of treatment up to 2 years
measure: Incidence of antibodies against LJM716
timeFrame: up to 10 cycle ( 1cycle = 28 days)
Other outcomes:
Locations:
city: Koto
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.