NSCLCPhase 1NCT02145637
Phase I Study of the Combination of Afatinib and Ruxolitinib in Patients With Treatment-refractory Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Afatinib plus Ruxolitinib combination therapy in people with NSCLC, run by Yonsei University.
Trial summary
This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Afatinib plus Ruxolitinib combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2015to 9 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 4 NSCLC patients
- disease progression after platinum doublet (all), EGFR TKI (if EGFR mutant), and crizotinib (if ALK positive)
- Men and women aged 20 years or older
- Recovery from previous drug-related toxicity: CTCAE 4.03 ≤ Grade 1
- ECOG 0 or 1
- able to orally take and retain drug
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- have a measurable or unmeasurable lesion under RECIST 1.1 Criteria
- have proper hematological, renal, and hepatic functions
- intention to use an acceptable contraception
- able to read and understand the informed consent form
Who cannot join
- previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days
- Clinically significant gastrointestinal disorder or malabsorption syndrome
- Acute digestive disorder
- major organ failure
- Significant cardiac disorders
- major operation of a main organ in 4 weeks
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- Untreated symptomatic brain metastasis
- pregnant or nursing
- previously diagnosed Interstitial lung disease(ILD)
- previously treated with irreversible pan-HER inhibitor including Afatinib or Ruxolitinib
- previously experienced hypersensitivity to an ingredient of the study drug
- must receive CYP3A4 inducer or inhibitor persistently during the study period.
- HIV positive or active hepatitis
- threatening patient's safety is predicted
About this study
This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.
- Conditions
- NSCLC
- Being tested
- Afatinib plus Ruxolitinib combination therapy
- Keywords
- Cancer, Lung cancer, Head and neck squamous cell carcinoma, Afatinib, Ruxolitinib, EGFR, JAK, STAT
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib plus Ruxolitinib combination therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Afatinib plus Ruxolitinib combination (single arm) | Experimental | Not described Receives: Drug: Afatinib plus Ruxolitinib combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To set a recommended phase II dose (RP2D)
We will set a recommended phase II dose (RP2D) using conventional 3+3 deisgn.
Measured: 36 days
Secondary outcomes (5)
Safety and tolerability (dose relating toxicity; DLT)
Adverse events (AEs) will be assessed according to NCI common toxicity criteria (CTC) version 4.03.
Measured: 1year
Overall response rate (ORR)
Response and progression will be evaluated in this study using modified international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Measured: 1year
Progression free survival (PFS)
PFS will be defined as the start of the treatment to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator.
Measured: 1year
Overall survival (OS)
OS will be defined as the start of the treatment to the date of death due to any cause.
Measured: 1year
Pharmacodynamic biomarker
The biomarkers marker related with EGFR and JAK/STAT pathway as well as gene analysis, using peripheral blood mononuclear cell(PBMC), circulating tumor cell (CTC) and skin and tumor tissue sample will be analyzed.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study start7 May 2015
- Primary completion9 Nov 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145637
- Sponsor's protocol ID
- 4-2013-0405
- Status last verified
- Mar 2018
- First submitted
- 23 Apr 2014
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park JS, Hong MH, Chun YJ, Kim HR, Cho BC. A phase Ib study of the combination of afatinib and ruxolitinib in EGFR mutant NSCLC with progression on EGFR-TKIs. Lung Cancer. 2019 Aug;134:46-51. doi: 10.1016/j.lungcan.2019.05.030. Epub 2019 May 28.
PubMed 31319994
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Combination of Afatinib and Ruxolitinib in Patients With Treatment-refractory Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02145637
- Acronym / sponsor ID
- 4-2013-0405
- Conditions
- NSCLC
- Keywords
- Cancer, Lung cancer, Head and neck squamous cell carcinoma, Afatinib, Ruxolitinib, EGFR, JAK, STAT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 May 2015
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase Ib study will investigate dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of afatinib and ruxolitinib combination therapy, based on the preclinical data that inhibition of IL-6R/JAK1 signal transmission pathway will increase sensitivity to afatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib plus Ruxolitinib combination (single arm) | Experimental | Drug: Afatinib plus Ruxolitinib combination therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Stage 4 NSCLC patients
- disease progression after platinum doublet (all), EGFR TKI (if EGFR mutant), and crizotinib (if ALK positive)
- Men and women aged 20 years or older
- Recovery from previous drug-related toxicity: CTCAE 4.03 ≤ Grade 1
- ECOG 0 or 1
Key exclusion criteria (14 listed)
- previous chemotherapy, radiation therapy, immunotherapy, or other anticancer therapy within 14 days
- Clinically significant gastrointestinal disorder or malabsorption syndrome
- Acute digestive disorder
- major organ failure
- Significant cardiac disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib plus Ruxolitinib combination therapy | Drug | Afatinib plus Ruxolitinib combination (single arm) |
Primary outcome
To set a recommended phase II dose (RP2D)
Time frame: 36 days
We will set a recommended phase II dose (RP2D) using conventional 3+3 deisgn.
5 secondary outcomes
Safety and tolerability (dose relating toxicity; DLT)
Time frame: 1year
Overall response rate (ORR)
Time frame: 1year
Progression free survival (PFS)
Time frame: 1year
Overall survival (OS)
Time frame: 1year
Pharmacodynamic biomarker
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Derived from this study: PubMed 31319994Park JS, Hong MH, Chun YJ, Kim HR, Cho BC. A phase Ib study of the combination of afatinib and ruxolitinib in EGFR mutant NSCLC with progression on EGFR-TKIs. Lung Cancer. 2019 Aug;134:46-51. doi: 10.1016/j.lungcan.2019.05.030. Epub 2019 May 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afatinib plus Ruxolitinib combination therapy in people with NSCLC, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To set a recommended phase II dose (RP2D) (time frame: 36 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02145637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.