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Tyrosine Kinase Inhibitor

Ceritinib + Docetaxel for Lung Cancer

Phase 1
Waitlist Available
Led By Andreas Saltos, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Potential participants with a prior history of brain metastases are eligible, provided: The brain metastases have been treated, The patient is asymptomatic from the brain metastases, Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study, The brain metastases are stable on pre-registration imaging, There is no evidence of leptomeningeal disease, Measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Life expectancy > 3 months, Must have adequate organ and marrow function, Must have adequate laboratory values, Participants of child bearing potential must not be pregnant and must use established contraceptive strategies as outlined in the study protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

Study Summary

This trial is testing the combination of two drugs, ceritinib and docetaxel, to see if it is effective and safe for people with NSCLC.

Who is the study for?
Adults over 18 with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) who've had up to three prior treatments, including a platinum-based agent and possibly one PD-1 or PD-L1 antibody regimen. They must have treated brain metastases if present, be able to provide recent tumor tissue samples, and not be pregnant while using contraception. Excluded are those with ALK rearrangements, EGFR mutations, other active cancers at high relapse risk, major surgery recovery within the last month, uncontrolled medical conditions or allergies to trial drugs.Check my eligibility
What is being tested?
The trial is testing the combination of Ceritinib (Zykadia®) and Docetaxel (Taxotere®) on participants with NSCLC. The goal is to determine the safest dose that can effectively treat this cancer type by observing both positive effects and any adverse reactions from this drug duo.See study design
What are the potential side effects?
Possible side effects include allergic reactions to either Ceritinib or Docetaxel; complications from pre-existing heart conditions; blood sugar control issues for diabetics; gastrointestinal problems affecting drug absorption; significant hair loss; and potential interactions with certain medications like CYP3A4/5 inhibitors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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If you had brain metastases before, you can join if: they were treated, you don't have symptoms, you stopped taking corticosteroids for them at least 7 days ago, they are not getting worse, and you meet other health requirements. If you can become pregnant, you must use birth control.
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I am willing and able to follow the study's schedule and procedures.
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My lung cancer is at an advanced stage (IIIB/IV).
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I've had 1-3 treatments for advanced cancer, including one with platinum and possibly one with PD-1/PD-L1 inhibitors.
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I can provide a recent biopsy sample or, if not possible, an older sample with approval.
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I am 18 years old or older.
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I have had radiation before but have recovered from the side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum Tolerated Dose (MTD)
Phase Ib: Overall Response (OR)
Secondary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase Ib Dose ExpansionExperimental Treatment2 Interventions
Treatment at recommended dose. Investigators plan to have 30 patients for the expansion cohort. This will include participants from the dose escalation portion receiving the recommended dose.
Group II: Phase I Dose EscalationExperimental Treatment2 Interventions
The design will recruit participants in cohorts of three patients each and will not allow for dose-skipping during escalation. A maximum of 18 participants will be enrolled for the phase I dose escalation. Three ceritinib dose levels have been identified for dose escalation (150 mg, 300 mg, and 450 mg), plus docetaxel at 75 mg. A backup dose (ceritinib 150 mg with docetaxel at 60 mg) is also prepared in case the three dose levels are too toxic. Therefore, four potential dose levels will be used for determination of maximum tolerated dose (MTD). The first cohort will start at dose level 1 (ceritinib 150 mg with docetaxel at 75 mg). Level -1 Backup Cohort: 150 mg ceritinib; 60 mg/m^2 docetaxel Level 1 Starting Cohort: 150 mg ceritinib; 75 mg/m^2 docetaxel Level 2 Cohort: 300 mg ceritinib; 75 mg/m^2 docetaxel Level 3 Cohort: 450 mg ceritinib; 75 mg/m^2 docetaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Ceritinib
2013
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,970 Total Patients Enrolled
Andreas Saltos, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Media Library

Ceritinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03611738 — Phase 1
Lung Cancer Research Study Groups: Phase I Dose Escalation, Phase Ib Dose Expansion
Lung Cancer Clinical Trial 2023: Ceritinib Highlights & Side Effects. Trial Name: NCT03611738 — Phase 1
Ceritinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03611738 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents of Docetaxel being studied in other research?

"As of now, 375 clinical trials are exploring the potentials benefits of Docetaxel. Of those experiments, 131 have entered Phase 3 and take place in 29502 distinct sites worldwide with Fuzhou, Fujian being host to a majority of them."

Answered by AI

Are there still openings for volunteers in this research endeavor?

"As listed on clinicaltrials.gov, this research effort has been recruiting patients since February 1st 2019 and the details have most recently been updated at the end of September 2022."

Answered by AI

Has Docetaxel been greenlit by the FDA?

"Docetaxel's safety rating is 1 due to the limited pre-existing data regarding its efficacy and safety, as this trial marks Phase 1."

Answered by AI

What is the aggregate population size of individuals participating in this clinical trial?

"Affirmative. Clinicaltrials.gov provides evidence that this investigation, which was initially posted on February 1st 2019, is currently seeking participants. This study demands 48 patients from 2 separate sites."

Answered by AI

In what contexts is Docetaxel typically prescribed?

"Docetaxel is typically prescribed for amino acid supplementation, but has also seen success in treating brca1 gene mutations, neoplasm metastasis and metastatic bladder cancer."

Answered by AI
~4 spots leftby May 2025