Trials / Terminated
TerminatedNCT02465528
Ceritinib Rare Indications Study in ALK+ Tumors
A Phase II, Open Label, Multi-center, Multi-arm Study of Ceritinib in Patients With Advanced Solid Tumors and Hematological Malignancies Characterized by Genetic Abnormalities of Anaplastic Lymphoma Kinase (ALK)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).
Conditions
- Tumors With Aberrations in ALK
- Anaplastic Large Cell Lymphoma
- Inflammatory Myofibroblastic Tumor
- Glioblastoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ceritinib (LDK378) | Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib. |
Timeline
- Start date
- 2016-05-06
- Primary completion
- 2018-08-20
- Completion
- 2018-08-20
- First posted
- 2015-06-08
- Last updated
- 2019-12-27
- Results posted
- 2019-10-21
Locations
14 sites across 8 countries: Czechia, Denmark, France, Israel, Italy, South Korea, Spain, Thailand
Source: ClinicalTrials.gov record NCT02465528. Inclusion in this directory is not an endorsement.