Lung CancerPhase 1/2NCT02155465

Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

A Phase 1/2 study testing Ruxolitinib and Erlotinib in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a phase 2 study. The goal of this study is to find out what effects, good and/or bad, taking erlotinib and ruxolitinib has on the patients and on lung cancer. Erlotinib and ruxolitinib are FDA approved for other indications, but the use of erlotinib and ruxolitinib together has not been studied before and is… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Ruxolitinib and Erlotinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 6 sitesUnited States
Study dates: Jun 2014to Oct 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Pathologic evidence of advanced (non-operable or metastatic) biopsy-proven stage IV or recurrent lung cancer reviewed at MSKCC.
a documented somatic activating mutation in EGFR (including but not limited to Exon 19 deletion or L858R)
Radiographic progression during treatment with erlotinib. Prior chemotherapy regimens are permitted.
Received erlotinib or other EGFR TK treatment for at least 2 weeks prior to enrollment
Measurable (RECIST 1.1) indicator lesion not previously irradiated
Must have undergone biopsy after development of acquired resistance to erlotinib (which is performed as standard of care) with adequate tissue to determine EGFR T790M and tumor histology. Slides from an outside institution may be used.

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KPS ≥ 70%
Age>18 years old
Patients must have adequate organ function:
AST, ALT, Alk phos ≤ 3.0 x ULN
Total bilirubin ≤ 2.0 x ULN
Creatinine <2.0 X upper limit of normal and/or a creatinine clearance ≥ 60ml/min
Absolute neutrophil count (ANC) ≥1,000 cells/mm³.
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0g/dL.

Who cannot join

Concurrent therapy with a potent CYP3A4 inducer or inhibitor. Subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin study treatment after 1 week or 5 half-lives, whichever is longer.
Patients with symptomatic brain metastasis requiring escalating doses of steroids.
Any type of systemic therapy (chemotherapy or experimental drugs) within 3 weeks of starting treatment on protocol except for erlotinib or other EGFR TKI.
Any radiation within 2 weeks prior to starting treatment on protocol
Patients with ≥ grade 2 or greater diarrhea despite maximal medical management due to medications or a medical condition such as Crohn's disease, malabsorption.
Inadequate recovery from any toxicities related to prior treatment (to Grade 1 or baseline).

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Pregnant or lactating women
Patients who have received prior treatment with JAK inhibitor
Previously or current malignancies at other sites within the last 2 years, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, prostate cancer that does not require active treatment per National Comprehensive Cancer Network (NCCN) guidelines, superficial bladder cancer or other noninvasive indolent or stage 1 malignancy without sponsor approval.
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, or symptomatic arrythmias requiring therapy,
Chronic or current active infections requiring systemic antibiotics, antifungals or antiviral therapy.
Known human immunodeficiency virus infection, or hepatitis B virus (HBV) viremia or hepatitis C virus (HCV) viremia. Screening for the study does not require assessment for these infections if not already known.
Any other condition that, in the opinion of the Investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York
Memoral Sloan Kettering Cancer Center at Phelps
Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: A Phase 1/2 Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

Conditions: Lung Cancer
Being tested: Ruxolitinib, Erlotinib
Keywords: Ruxolitinib, Erlotinib, EGFR-mutant, 14-043
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RuxolitinibDrug
Ruxolitinib 10mg PO BID
Ruxolitinib 15mg PO BID
Ruxolitinib 20mg PO BID
ErlotinibDrug
Erlotinib 150mg PO QD

Study groups in NCT02155465
Study group	Role	What they receive
Ruxolitinib and Erlotinib	Experimental	Phase I The study will follow a standard 3+3 dose escalation trial design. Three to six patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (21 days) before a dose escalation decision is made. Phase II Once the MTD has been determined, patients will be enrolled in the phase 2 portion of the single-arm, two-stage, open-label study to determine efficacy of erlotinib and ruxolitinib. Patients will receive erlotinib and ruxolitinib at the MTD established in the phase I portion. The patient take their previous dose of erlotinib if it is less than 150mg daily. Receives: Drug: Ruxolitinib; Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximally Tolerated Dose (MTD) (Phase I)
Measured: 1 year
Assess Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), at least a 20% increase in the sum of the diameter of the target lesions or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Measured: 1 year

Secondary outcomes (2)

Number of Participants With NCI CTCAE Toxicity
Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.
Measured: 2 years
Progression-free Survival
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Oct 2017

First posted4 Jun 2014 (estimated)
Study startJun 2014
Primary completionOct 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02155465
Sponsor's protocol ID: 14-043
Status last verified: Oct 2017
First submitted: 2 Jun 2014
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib
ClinicalTrials.gov ID: NCT02155465
Acronym / sponsor ID: 14-043
Conditions: Lung Cancer
Keywords: Ruxolitinib, Erlotinib, EGFR-mutant, 14-043
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Collaborators: Incyte Corporation
Study start: Jun 2014 (actual)
Primary completion: Oct 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 4 Jun 2014 (estimated)
Results: Posted 3 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ruxolitinib and Erlotinib	Experimental	Drug: Ruxolitinib, Drug: ErlotinibPhase I The study will follow a standard 3+3 dose escalation trial design. Three to six patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (21 days) before a dose escalation decision is made. Phase II Once the MTD has been determined, patients will be enrolled in the phase 2 portion of the single-arm, two-stage, open-label study to determine efficacy of erlotinib and ruxolitinib. Patients will receive erlotinib and ruxolitinib at the MTD established in the phase I portion. The patient take their previous dose of erlotinib if it is less than 150mg daily.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Pathologic evidence of advanced (non-operable or metastatic) biopsy-proven stage IV or recurrent lung cancer reviewed at MSKCC.
a documented somatic activating mutation in EGFR (including but not limited to Exon 19 deletion or L858R)
Radiographic progression during treatment with erlotinib. Prior chemotherapy regimens are permitted.
Received erlotinib or other EGFR TK treatment for at least 2 weeks prior to enrollment
Measurable (RECIST 1.1) indicator lesion not previously irradiated

Key exclusion criteria (13 listed)

Concurrent therapy with a potent CYP3A4 inducer or inhibitor. Subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin study treatment after 1 week or 5 half-lives, whichever is longer.
Patients with symptomatic brain metastasis requiring escalating doses of steroids.
Any type of systemic therapy (chemotherapy or experimental drugs) within 3 weeks of starting treatment on protocol except for erlotinib or other EGFR TKI.
Any radiation within 2 weeks prior to starting treatment on protocol
Patients with ≥ grade 2 or greater diarrhea despite maximal medical management due to medications or a medical condition such as Crohn's disease, malabsorption.

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
RuxolitinibRuxolitinib 10mg PO BID Ruxolitinib 15mg PO BID Ruxolitinib 20mg PO BID	Drug	Ruxolitinib and Erlotinib
ErlotinibErlotinib 150mg PO QD	Drug	Ruxolitinib and Erlotinib

Primary outcome

Maximally Tolerated Dose (MTD) (Phase I)
Time frame: 1 year
Assess Overall Response Rate
Time frame: 1 year
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), at least a 20% increase in the sum of the diameter of the target lesions or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

2 secondary outcomes

Number of Participants With NCI CTCAE Toxicity
Time frame: 2 years
Progression-free Survival
Time frame: 2 years

Results and safety

Results posted to the registry on 3 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Level 1	3	3
Phase 1: Level 2	3	3
Phase 1: Level 3	6	6
PHASE 2: 20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD	2	2
PHASE 2: 20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd	1	1
PHASE 2 MTD: 20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd	2	2
PHASE 2 MTD: 20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd	5	5

Primary outcome: Maximally Tolerated Dose (MTD) (Phase I)

Time frame: 1 year. Number. Unit: mg

Measure	Phase I Participants n = 12	Phase II Participants n = 0
Erlotinib Daily	150	–
Ruxolitinib Twice Daily	20	–

Population analysed: Maximally Tolerated Dose (MTD) is determined by evaluating all Phase I participants as a whole. All Phase I participants are evaluated together to determine the MTD.

Primary outcome: Assess Overall Response Rate

Time frame: 1 year. Number (95% Confidence Interval). Unit: % of participants with partial response

Measure	Ruxolitinib and Erlotinib n = 22
Value	5 (0 to 13)

Population analysed: Participants response to study treatment were combined and evaluated to determine an overall response rate.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Level 1	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
Phase 1: Level 2	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Phase 1: Level 3	2 of 6 (33.3%)	5 of 6 (83.3%)	5 of 6
PHASE 2: 20mg Ruxolitinib PO BID/ 75 mg Erlotinib PO QD	0 of 2 (0%)	2 of 2 (100%)	2 of 2
PHASE 2: 20mg Ruxolitinib PO BID / 50 mg Erlotinib PO qd	1 of 1 (100%)	1 of 1 (100%)	1 of 1
PHASE 2 MTD: 20mg Ruxolitinib PO BID / 150 mg Erlotinib PO qd	0 of 2 (0%)	2 of 2 (100%)	1 of 2
PHASE 2 MTD: 20mg Ruxolitinib PO BID / 100 mg Erlotinib PO qd	1 of 5 (20%)	5 of 5 (100%)	3 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.

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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.

Helena Yu, MD principal investigator

Memorial Sloan Kettering Cancer Center

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ruxolitinib and Erlotinib in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

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 15 inclusion and 13 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximally Tolerated Dose (MTD) (Phase I) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT02155465.

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 16 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.