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

NCT01911936 | Completed Phase 1 DMC

• 1 other identifier: CLJM716X1101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Neoplasms

Keywords

CLJM716,; Japanese patients,; Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  First cycle (28 days)

Secondary Outcomes (4)

• Frequency and severity of adverse events, number of and reasons for

  from informed consent till 30 days after end of treatment

• LJM716 serum concentration-time- profile and estimated PK

  up to 10 cycle (1 cycle = 28 days)

• Tumor response according to RECIST 1.1

  every 2 months until end of treatment up to 2 years

• Incidence of antibodies against LJM716

  up to 10 cycle ( 1cycle = 28 days)

Study Arms (1)

LJM716

EXPERIMENTAL

Drug: LM716

Interventions

LM716 DRUG

LJM716

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Koto, Tokyo, 135-8550, Japan

Location

Novartis Investigative Site

Fukuoka, 811-1395, Japan

Location

Related Publications (1)

• 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.

  PMID: 27942917 DERIVED

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 30, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 17, 2020

Record last verified: 2015-05

Locations

JP (2)