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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01546428
• Collaborator: (none)
• Enrollment: 44
• Locations: 2
• Arm: 1
• Duration (Months): 47
• Patients Per Site: 22
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: INC280	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INC280	Drug: INC280

Outcome Measures

Primary Outcome Measures

1. Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part [4 weeks]

   Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.

Secondary Outcome Measures

1. Incidence and severity of adverse events and serious adverse events, changes in laboratory values [4 months]

   Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.

2. Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2 [1 month]

   Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.

3. Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM [4 months]

   Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Kashiwa	Chiba	Japan	277-8577
2	Novartis Investigative Site	Fukuoka		Japan	811-1395

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01546428
• Other Study ID Numbers: CINC280X1101
• First Posted: Mar 7, 2012
• Last Update Posted: Dec 19, 2020
• Last Verified: Jun 1, 2016

• Keywords provided by Novartis Pharmaceuticals: c-MET; Advanced solid tumor
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Dec 19, 2020