Bioavailability and Food Effect Study of TKI258 (CSF Capsules vs. FMI Capsules)in Adult Patients With Advanced Solid Tumors
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01030055
First received: December 8, 2009
Last updated: December 5, 2012
Last verified: December 2012
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Purpose
This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Cancer Tumors |
Drug: TKI258 (dovitinib) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258, and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Determine the relative bioavailability of the final market image form of TKI258 (monohydrate capsules) as compared to the clinical service form of TKI258 (anhydrate capsules) [ Time Frame: 9 days ] [ Designated as safety issue: No ]
- Determine the effect of food on the bioavailability of TKI258 [ Time Frame: 22 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Characterize the safety and tolerability of TKI258, including acute and chronic toxicities [ Time Frame: Up to 28 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
- Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors. [ Time Frame: Every 8 weeks until progression of disease ] [ Designated as safety issue: No ]
| Enrollment: | 82 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TKI258 - bioavailability |
Drug: TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)
Other Name: dovitinib
|
| Experimental: TKI258 - food |
Drug: TKI258 (dovitinib)
bioavailability (anhydrate capsules) food (monohydrae capsules)
Other Name: dovitinib
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with an advanced solid tumor, except breast cancer,which has progressed despite standard therapy, or for which no standard therapy exists
- World Health Organization (WHO) performance status ≤ 2
- Patient must meet protocol-specified laboratory values
Exclusion Criteria:
- Patients with brain cancer
- Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- Patients who have not recovered from previous anti-cancer therapies
- Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030055
Locations
| United States, California | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| UCLA/ University of California Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| United States, North Carolina | |
| Duke University Medical Center Cancer Dept | |
| Durham, North Carolina, United States, 27710 | |
| United States, Utah | |
| University of Utah / Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
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: | NCT01030055 History of Changes |
| Other Study ID Numbers: | CTKI258A2112 |
| Study First Received: | December 8, 2009 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Neoplasms Cancer Tumors Administration, oral Capsules CHIR258 CHIR-258 |
CHIR 258 TKI258 TKI-258 TKI 258 Bioavailability Food |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 13, 2013