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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03611738
Other study ID # MCC-19656
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date February 1, 2019
Est. completion date April 2025

Study information

Verified date May 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ceritinib
Ceritinib daily by mouth (PO) with food, according to the dosage schedule outlined in the treatment arm.
Docetaxel
Docetaxel intravenously (IV) every 3 weeks, according to the dosage schedule outlined in the treatment arm.

Locations

Country Name City State
United States Advent Health Orlando Orlando Florida
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: Maximum Tolerated Dose (MTD) Maximum tolerated dose corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients. Up to 6 months
Primary Phase Ib: Overall Response (OR) OR: Defined as the participant being alive and the tumor size evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on subsequent imaging assessment consistent with a complete response (CR) or partial response (PR). Overall response rates will be calculated with a 2-sided 95% confidence interval (CI). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm (< 1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Up to 30 months
Secondary Progression-free Survival (PFS) PFS: Defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Up to 30 months
Secondary Overall Survival (OS) OS: Defined as the time from study entry to death due to any cause, will be summarized with the Kaplan-Meier curve. Up to 30 months
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