Phase I Dose Escalating Study of TKI258
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01471548
First received: November 10, 2011
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: TKI258 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) of TKI258 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Antineoplastic activity based on the RECIST criteria [ Time Frame: 22 months ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | September 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TKI258
dose escalation
|
Drug: TKI258
Other Name: Dovitinib
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent must be obtained prior to any screening procedures
- Advanced solid tumors
- Agreement to remaining hospitalized
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Pregnant women. Male and female patients of reproductive potential must agree to employ an effective method of birth control
- Demonstrate the specific hematological /blood chemistry laboratory values
Exclusion Criteria:
- Receipt of any investigational compound within 28 days prior to the first dose of study drug or failure to have recovered from the side effects of such prior therapy
- Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and radiation therapy, within 28 days (with some exceptions)
- Patients with CNS and/or leptomeningeal disease metastases
- Presence or history of thromboembolic or cerebrovascular events
- Impaired cardiac function or clinically significant cardiac disease
- Malabsorption syndrome or uncontrolled gastrointestinal toxicities
- Patients known to be HIV- or HBV- or HCV- positive
- Patients with acute or chronic uncontrolled infection
- Patients who have undergone surgery with general anesthesia for any cause within 28 days prior to the first dose of study drug
- Patients who have been receiving anticoagulant therapy
- Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14 days prior to the first dose of study drug
- Patients who have been administering concomitant medication which may prolong the QTc interval
- Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
- Patients with a large volume of ascitic and/or pleural fluid which requires drainage
- Patients with any bone fractures
- Deemed otherwise unsuitable by the investigator
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471548
Locations
| Japan | |
| Novartis Investigative Site | |
| Takatsuki, Osaka, Japan, 569-8686 | |
| Novartis Investigative Site | |
| Hidaka, Saitama, Japan, 350-1241 | |
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: | NCT01471548 History of Changes |
| Other Study ID Numbers: | CTKI258A1101 |
| Study First Received: | November 10, 2011 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Food and Drug Administration Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Novartis:
|
tumor cancer phase1 TKI258 |
ClinicalTrials.gov processed this record on May 16, 2013