Trials / Completed
CompletedNCT01576380
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients
A Single-arm, Multi-center, Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Adult Patients With Advanced Scirrhous Gastric Carcinoma That Have Progressed After One or Two Prior Systemic Treatments
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.
Conditions
- Adenocarcinoma, Scirrhous
- Linitis Plastica
- Stomach Neoplasms
- Stomach Diseases
- Neoplasms by Site
- Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TKI258 | TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week. |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2012-04-12
- Last updated
- 2017-02-27
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01576380. Inclusion in this directory is not an endorsement.