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Trial record 1 of 1 for:    NCT02473731
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A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT02473731
First received: June 11, 2015
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to evaluate the activity and safety of KTN3379 in head and neck cancer patients and to explore downstream molecular pathways to identify tumor response and resistance mechanisms by evaluating various biomarkers before and after treatment.

Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Biological: KTN3379
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • Change in pErbB3 levels in tumor tissue [ Time Frame: 4 weeks ]
    Reduction in pErbB3 levels


Secondary Outcome Measures:
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 6 weeks ]
    Adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, radiological assessments, vital signs, electrocardiograms (ECGs), and physical examinations.

  • Ki67 proliferative index in tumor tissue [ Time Frame: 4 weeks ]
    Ki67 proliferative index in tumor tissue before and after treatment

  • Changes in tumor measurements (RECIST 1.1 measurements) [ Time Frame: 4 weeks ]
    RECIST 1.1 measurements before and after treatment

  • Pharmacokinetics (Peak plasma concentrations of KTN3379 Trough plasma concentrations of KTN3379) [ Time Frame: 4 weeks ]
    Peak plasma concentrations of KTN3379 Trough plasma concentrations of KTN3379

  • Anti drug antibodies [ Time Frame: 6 weeks ]
    Measurement of anti KTN3379 antibodies in blood


Estimated Enrollment: 29
Study Start Date: October 2015
Estimated Study Completion Date: April 14, 2017
Primary Completion Date: September 22, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treatment with KTN3379 in HPV positive head and neck cancer patients
Biological: KTN3379
Experimental: B
Treatment with KTN3379 in HPV negative head and neck cancer patients
Biological: KTN3379

Detailed Description:
This is an open-label study in patients with squamous cell carcinoma of the head and neck (SCCHN) scheduled for surgery. Two cohorts of SCCHN patients, HPV negative and HPV positive, will be treated with KTN3379 to evaluate effects on ErbB3 phosphorylation and other biomarkers in tumor tissue. The KTN3379 treatment duration is within the expected window of time that elapses from initial patient evaluation by a surgeon to performance of surgery. Paired preoperative and postoperative tumor specimen analyses allow evaluation of proliferation, ErbB3 related biomarkers, pErbB3 modulation and pharmacodynamic changes in downstream molecular pathways.
  Eligibility

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

Inclusion Criteria:

  1. Histologically or cytologically confirmed primary, untreated SCCHN including variants. Patients must be candidates for surgical resection. Primary tumors of oral cavity, oropharynx, hypopharnyx or larynx are included.
  2. Written informed consent and any locally required authorization (e.g., HIPAA in the USA) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  3. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 60 days after the final dose of KTN3379. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as 12 months with no menses without an alternative medical cause)
  4. Nonsterilized males who are sexually active with a female partner of child-bearing potential must, with their partner, use 2 acceptable methods of effective contraception from Day 1 through 60 days after receipt of the final dose of KTN3379.
  5. Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  6. Adequate bone and marrow function as defined below:

    • Hemoglobin ≥ 10 g/dL
    • Absolute neutrophil count ≥ 1500/mm3
    • Platelet count ≥ 100,000/mm3
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ×ULN
    • Bilirubin ≤ 1.5 × ULN except for cases of documented or suspected Gilbert's disease, in which bilirubin must be ≤ 5 × ULN
    • Serum creatinine ≤ 1.5 g/dL
    • Normal PT or INR and aPTT

Exclusion Criteria:

  1. Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
  2. Immunosuppressive or systemic steroids medication within 7 days before the first dose of KTN3379 (inhaled and topical corticosteroids are permitted).
  3. Another invasive malignancy within 2 years prior to enrollment except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has/have been surgically cured
  4. Major surgical procedure within 30 days prior to Day 1 or incomplete recovery from any prior surgery
  5. Pregnancy or lactation
  6. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled or idiopathic hypotension, unstable angina pectoris, cardiac arrhythmia including atrial fibrillation, significant cardiac conduction abnormalities including prolongation of QTc interval or BBB, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
  7. Patients with a left ventricular cardiac ejection fraction < 50% as assessed by an echocardiogram or MUGA scan
  8. Patients with prior primary treatment for head and neck cancer (e.g. chemoradiation or radiation alone).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02473731

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Celldex Therapeutics
  More Information

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT02473731     History of Changes
Other Study ID Numbers: KTN3379-CL-002
Study First Received: June 11, 2015
Last Updated: April 4, 2017

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on April 21, 2017