A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546428
• Other study ID #: CINC280X1101
• Status: Completed
• Phase: Phase 1
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.

• Eastern Cooperative Oncology Group (ECOG) Performance Status = 2

• Good organ (hepatic, kidney, BM) function at screening/baseline visit.

Exclusion criteria:

• Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.

• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.

• Undergone a bone marrow or solid organ transplant.

• Women who are pregnant or breast feeding.

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• INC280

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Kashiwa	Chiba

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 (DLT) in the dose escalation part	Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.	4 weeks
Secondary	Incidence and severity of adverse events and serious adverse events, changes in laboratory values	Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.	4 months
Secondary	Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2	Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.	1 month
Secondary	Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM	Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM	4 months

External Links

•   Results for CINC280X1101 can be found on the Novartis Clinical Trial Results Website