A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified November 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01546428
First received: February 27, 2012
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumor |
Drug: INC280 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.
Secondary Outcome Measures:
- Incidence and severity of adverse events and serious adverse events, changes in laboratory values [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
- Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2 [ Time Frame: 1 month ] [ Designated as safety issue: No ]Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.
- Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM [ Time Frame: 4 months ] [ Designated as safety issue: No ]Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: INC280 | Drug: INC280 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546428
Contacts
| Contact: Novartis Pharmaceuticals | +1(800)340-6843 |
Locations
| Japan | |
| Novartis Investigative Site | Recruiting |
| Kashiwa, Chiba, Japan, 277-8577 | |
| Novartis Investigative Site | Recruiting |
| Fukuoka, Japan, 811-1395 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01546428 History of Changes |
| Other Study ID Numbers: | CINC280X1101 |
| Study First Received: | February 27, 2012 |
| Last Updated: | November 26, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Novartis:
|
c-MET Advanced solid tumor |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013