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Ruxolitinib in Operable Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03153982
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The purpose of this study is to assess the safety and efficacy of ruxolitinib in patients with operable Head and neck squamous cell carcinoma (HNSCC) who are planned for definitive surgery.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Ruxolitinib Phase 2

Detailed Description:

Patients will take ruxolitinib twice daily during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tablets (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.

Dose will be assigned based on participant platelet count at baseline:

  1. Patients with a platelet count of 200,000 or greater will take 20 mg twice daily (four 5mg tablets in the morning and four 5mg tablets in the evening);
  2. Patients with a platelet count between150,000 and 200,000 will take 15 mg twice daily (three 5 mg tablets in the morning and three 5 mg tablets in the evening).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Effects and Predictive Biomarkers of Janus Kinases (JAK)/Signal Transducer and Activator of Transcription (STAT) Inhibition With Ruxolitinib in Operable Head and Neck Cancer: a Window Trial
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Head and neck squamous cell carcinoma

Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery.

Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg).

Drug: Ruxolitinib
15 mg or 20 mg (three or four 5 mg tablets) by mouth twice daily
Other Name: Jakafi




Primary Outcome Measures :
  1. Change in Tumor Size [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]
    Measured as a proportional percent (range -100% to +100%) from baseline to day of final dose of ruxolitinib


Secondary Outcome Measures :
  1. Safety- toxicity, surgical complications, and length of hospital stay [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]
    Safety will be reported descriptively, including tabulation of toxicities according to NCI CTCAE v.4, surgical complications, and length of hospital stay.

  2. Ki-67 [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]
    The Ki-67 proliferative index will be measured in baseline and post-treatment tumor tissue.

  3. Biomarkers [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]
    Biomarkers of ruxolitinib response or resistance will be analyzed for correlations with change in tumor size and change in Ki-67. Biomarkers to be analyzed included baseline activation and/or modulation of additional JAK/STAT3 signaling pathway proteins, baseline Src homology 2 domain-containing protein tyrosine phosphatase 2 (SHP-2) overexpression, and Reverse-phase protein array (RPPA).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed, primary or recurrent, head and neck squamous cell carcinoma, including variants. Patients must have at least one measureable lesion in accordance with RECIST 1.1 (tumor diameter ≥ 1 cm; short-axis lymph node diameter ≥ 1.5 cm) OR by caliper measurement (tumor diameter ≥ 1 cm). Any diagnostic pretreatment biopsy sample is acceptable including fine needle aspiration (FNA).
  2. Primary tumors of any head and neck (oral cavity, oropharynx, hypopharynx, or larynx) site will be included.
  3. Surgical resection of head and neck must be planned, either as primary treatment or salvage. Patients must have submitted adequate pretreatment archival or fresh tissue.
  4. Age ≥ 18 years.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See Appendix 1).
  6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (sensitivity ≤ 25 human chorionic gonadotropin (HCG) IU/L) within 4 weeks prior to registration and will be repeated within 72 hours prior to the start of study drug administration.
  7. Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 12 weeks after study drug is stopped. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
  8. Adequate hematologic, renal and hepatic function, as defined by:

    1. Absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 150,000/ul.
    2. Creatinine ≤ 1.5 x institutional upper limit of normal (ULN).
    3. Bilirubin ≤ 1.5 x ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN.
  9. Have signed written informed consent

Exclusion Criteria:

  1. Subjects who fail to meet the above criteria.
  2. Prior therapy for head and neck cancer is allowed, and the number of treatments is not limited. However, any systemic therapy should have been completed at least 30 days prior to study enrollment. Any radiation to the head and neck should have been completed at least 30 days prior to study enrollment. Palliative radiation outside of the head and neck does not require a washout.
  3. Pregnancy or breastfeeding. Women (patients or partners of male patients) of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. All WOCBP must have a negative pregnancy test within 4 weeks prior to registration, and this must be repeated within 72 hours prior to first receiving ruxolitinib. If the pregnancy test is positive, the patient must not receive ruxolitinib and must not be enrolled in the study.
  4. Any unresolved chronic toxicity ≥ grade 2 from previous anticancer therapy (except alopecia and anemia), according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
  5. Current active infection requiring systemic antibiotic or antifungal therapy.
  6. Acute hepatitis or known HIV.
  7. Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment.
  8. New York Heart Association (NYHA) Class III or IV heart disease.
  9. History of thromboembolic event or other condition currently requiring anticoagulation with warfarin (coumadin). Patients who are treated with low molecular weight heparin or fondaparinux are eligible.
  10. History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders (e.g., von Willebrand's disease, diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies, or ongoing or recent (≤ 3 months) significant gastrointestinal bleeding
  11. Concomitant Medications, any of the following should be considered for exclusion: Strong CYP3A4 inhibitors: (Patients must discontinue drug 7 days prior to starting ruxolitinib), including but not limited to boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole. In addition, patients will be instructed to avoid grapefruit or grapefruit juice, starfruit, or seville oranges.
  12. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153982


Contacts
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Contact: William Ryan, MD 877-827-3222 cancertrials@ucsf.edu
Contact: Carter Hultman 415-502-4707 carter.hultman@ucsf.edu

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Clinical Trials Office    866-278-1554    UACC-C3@uacc.arizona.edu   
Sub-Investigator: Julie Bauman, MD         
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Carter Hultman, CCRC    415-502-4707    Carter.Hultman@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Incyte Corporation
Investigators
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Principal Investigator: William Ryan, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03153982    
Other Study ID Numbers: 16201
NCI-2017-02304 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
HNSCC
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site