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Trial record 2 of 35 for:    tas-102

TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003)

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ClinicalTrials.gov Identifier: NCT02920476
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Taiho Oncology, Inc.
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This is a non-randomized, open label, sequentially enrolling phase II study with a Simon two-step enrollment design to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. The trial therapy of TAS-102 is to be administered orally at 35 mg/m2 each dose twice daily. The primary objective of the trial is to determine the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of unresectable or metastatic recurrent squamous non-small cell lung cancers.

Condition or disease Intervention/treatment Phase
Squamous Cell Lung Carcinoma Drug: TAS-102 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Carcinoma of the Lung
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment arm
TAS-102
Drug: TAS-102

Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.

Days 6 through 7: Rest

Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.

Days 13 through 28: Rest

Other Name: Lonsurf



Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 1 year ]
    To determine the percentage of subjects who achieve an objective response by RECIST criteria, as observed after two, four, and six cycles of therapy


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
    To evaluate the qualitative and quantitative toxicities, and reversibility of toxicities, of this treatment by National Cancer Institute (NCI) Common Terminology Criteria (CTC) Version 4.0.3 criteria

  2. Progression Free Survival (PFS) [ Time Frame: 1 year ]
    To determine the progression-free survival, in months, of subjects receiving TAS 102 for the treatment of unresectable or metastatic recurrent squamous cell lung cancers

  3. Clinical Benefit Rate [ Time Frame: 1 year ]
    To determine the percentage of subjects who derive clinical benefit (objective response + stable disease)

  4. Overall Survival (OS) [ Time Frame: 1 year ]
    To determine the overall survival in months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Those who will be eligible will be all patients with unresectable and/or metastatic squamous cell non-small cell lung cancer who have disease which has been previously treated with an Food & Drug Administration (FDA)- or National Comprehensive Cancer Network (NCCN)-approved platinum doublet and an immune checkpoint inhibitor. Patients who have not received such therapy must have medical reasons for not receiving such therapy, such as a prior history of an autoimmune disease. Those who have a molecularly targetable genetic mutation in their tumor must have also received the appropriate specific therapy for that mutation. All will be appropriate candidates for chemotherapy treatment.

Subjects must meet all of the additional following criteria to be eligible for study participation:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status <2
  • Life expectancy > 12 weeks
  • Male or female' age >18 years
  • Patients of childbearing potential must be using an effective means of contraception.
  • Histologic diagnosis of squamous non-small cell lung cancer that has been treated adequately in the metastatic or unresectable setting with a platinum doublet chemotherapy regimen and an immune checkpoint inhibitor, and now has evidence of disease progression. Patients who have not received an immune checkpoint inhibitor must have medical reasons for not receiving such therapy, such as a prior history of an autoimmune disease.
  • Patients who have received platinum-based doublet therapy in the neoadjuvant or adjuvant setting will only be eligible if they have experienced disease progression within 3 months of their last dose of cytotoxic chemotherapy.
  • Patients who have a neoplasm for which there currently exists an FDA-approved targeted therapy (such as to epidermal growth factor receptor [EGFR] activating mutations, or ALK or ROS1 gene rearrangements) must have received all such targeted therapies and either exhibited progressive disease through such treatments, or have been shown to be intolerant of such therapies, prior to enrollment on this study.
  • Baseline laboratory values (bone marrow, renal, hepatic):
  • Adequate bone marrow function:
  • Absolute neutrophil count >1000/µL
  • Platelet count >100'000/µL
  • Renal function:
  • Serum creatinine < 2.0 mg/dL
  • Hepatic function:
  • Bilirubin <1.5x upper limit of normal (ULN)
  • Serum calcium < 12 mg/dL
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 6 months after the last dose of study drug to minimize the risk of pregnancy. 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. WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
  • Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or
  • For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
  • Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 6 months following the last dose of study drug.
  • Subjects must have provided written informed consent and be willing to comply with all study-related procedures.

Exclusion Criteria:

  • Pregnant or lactating females
  • Patients with a mixed histology NSCLC, such as adenosquamous carcinoma, where the squamous component is <50% of the assessed lesion
  • Patients with a mixed histology where there are any small cell elements
  • Patients who have not received and progressed through, or been intolerant of, a commonly utilized platinum-doublet therapy (cisplatin or carboplatin paired with docetaxel, paclitaxel, nab-paclitaxel, gemcitabine, vinorelbine, etoposide or irinotecan) administered for the treatment of unresectable or metastatic lung cancer.
  • Patients who have not received and progressed through an immune checkpoint inhibitor unless they are medically ineligible to do so, such as due to a prior history of pneumonitis, nephritis or an autoimmune disease. Such patients receiving checkpoint inhibitor therapy must have been assessed for tumor response no earlier than after 12 weeks of therapy in order to rule out pseudoprogression.
  • Patients who have not received the appropriate prior targeted therapy for their lung cancer if eligible
  • Any invasive malignancy treated within 3 years prior to Cycle 1, Day 1
  • Myocardial infarction or ischemia within the 6 months before Cycle 1' Day 1
  • Uncontrolled' clinically significant dysrhythmia, or prolonged QT segment
  • Uncontrolled malignant disease in the central nervous system (previously treated disease is eligible, provided it has been radiographically stable for at least four weeks)
  • Radiotherapy within the 2 weeks before Cycle 1, Day 1. If any radiation has been administered to the target lesion there must be evidence of growth by radiographic assessments or physical examination
  • Major surgery within the 2 weeks before Cycle 1, Day 1
  • Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
  • Subjects must use an acceptable method to avoid pregnancy for the entire study period and for at least 6 months after the last dose of study drug.
  • History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
  • Subjects demonstrating an inability to comply with the study and/or follow-up procedures.

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): NCT02920476


Contacts
Contact: Alisha J. Daniels, MD, MHA (352) 294-8568 alisha.daniels@ufl.edu
Contact: Allison B. Trainor, MPH awickham@ufl.edu

Locations
United States, Florida
Malcom Randall VA Medical Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Allison Trainor, MPH    352-265-0680 ext 50703    awickham@ufl.edu   
Principal Investigator: Jennifer Duff, MD         
UF Health Cancer Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Allison B. Trainor, MPH       awickham@ufl.edu   
Sponsors and Collaborators
University of Florida
Taiho Oncology, Inc.
Investigators
Principal Investigator: Dennie Jones, MD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02920476     History of Changes
Other Study ID Numbers: IRB201601359
UF-STO-LUNG-003 ( Other Identifier: University of Florida )
IIT-USA-0113 ( Other Identifier: Taiho Oncology )
15277 ( Other Identifier: University of Florida )
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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.: No

Keywords provided by University of Florida:
lung
metastatic
carcinoma

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents