Trials / Active Not Recruiting
Active Not RecruitingNCT03611738
Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC
Phase I Study of Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to find out what effects (good and bad) ceritinib (Zykadia®) used in combination with docetaxel (Taxotere®) will have on participants and their cancer. The results will help to determine the best safe dose of the combination of the medications Ceritinib (Zykadia®) and docetaxel (Taxotere®) and to find out if this combination of drugs will help people that have this type of Non-small Cell Lung Cancer (NSCLC).
Detailed description
In this phase I/IB clinical trial, participants with non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy (maximum number of prior distinct regimens = 2) and are anaplastic lymphoma kinase (ALK)-negative/epidermal growth factor receptor (EGFR) wild-type (WT) will receive a combination of ceritinib and docetaxel. Study rationale is that targeting ALK- and EGFR-negative lung tumors with ceritinib and microtubule inhibitors results in synergistic antitumor effects. Therefore, treatment with ceritinib and docetaxel is a rational combination.
Conditions
- Non-small Cell Lung Cancer
- Lung Cancer
- Non-small Cell Lung Cancer Metastatic
- Non-small Cell Lung Cancer Stage IIIB
- Stage IV Non-small Cell Lung Cancer
- EGFR Negative Non-Small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ceritinib | Ceritinib daily by mouth (PO) with food, according to the dosage schedule outlined in the treatment arm. |
| DRUG | Docetaxel | Docetaxel intravenously (IV) every 3 weeks, according to the dosage schedule outlined in the treatment arm. |
Timeline
- Start date
- 2019-02-01
- Primary completion
- 2025-04-28
- Completion
- 2026-04-01
- First posted
- 2018-08-02
- Last updated
- 2026-02-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03611738. Inclusion in this directory is not an endorsement.