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TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003)

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ClinicalTrials.gov Identifier: NCT02921737
Recruitment Status : Suspended (accrual temporarily suspended for eligibility criteria revision)
First Posted : October 3, 2016
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Taiho Oncology, Inc.
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to evaluate the activity of TAS-102 in previously treated metastatic and locally advanced unresectable pancreatic cancer after progression through or intolerance to first or second line chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint is to determine the progression free survival (PFS) in subjects with unresectable pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: TAS-102 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of TAS-102 (Lonsurf) in Patients With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma After Progression Through First Line Chemotherapy
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm
TAS-102
Drug: TAS-102
TAS-102 (35 mg/m2/dose) orally 2 times daily beginning the morning of Day 1 of each cycle and ending the evening of Day 5 of each cycle, as well as beginning the morning of Day 8 and ending the evening of Day 12 of each cycle. No TAS-102 will be given on Days 6-7 or Days 13-28 of each cycle.
Other Name: Lonsurf




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 6 months ]
    To determine the progression free survival (PFS)


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 6 months ]
    To determine the objective response rate (ORR) by RECIST criteria

  2. Clinical Benefit Rate [ Time Frame: 6 months ]
    To determine the Clinical Benefit Rate (CR + PR + SD)

  3. Time to Progression (TTP) [ Time Frame: 6 months ]
    To determine the time to progression (TTP)

  4. Overall Survival (OS) [ Time Frame: 6 months ]
    To determine overall survival (OS)

  5. Safety and Tolerability of Toxicities and Reversibility of Toxicities [ Time Frame: 6 months ]
    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

  6. Drug Compliance Diary [ Time Frame: 6 months ]
    To determine subject compliance with oral therapy through measuring the amount of investigational agent taken compared to the amount intended as outlined in the protocol



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

Inclusion Criteria:

  • Histologic or cytologic confirmed adenocarcinoma of the pancreas.
  • Clinically metastatic or locally advanced unresectable disease as verified by radiographic imaging. Subjects without clear evidence of distant metastatic disease will be presented at multidisciplinary tumor board for discussion of disease resectability.
  • Documented progression or intolerance to first or second line chemotherapy which was prescribed for metastatic pancreatic adenocarcinoma or locally advanced unresectable disease. Intolerance is defined as any sign or symptom from chemotherapy that resulted in stopping the chemotherapy treatment prematurely before progression of disease or the subject's desire to stop treatment without evidence of progression.
  • TAS102 will be planned to start after disease progression on first-or second line chemotherapy, provided any prior chemotherapy-related toxicities have resolved to less than or equal to Grade 1 or baseline within 28 days of the date the subject signs the informed consent form. Grade 2 or greater toxicities including alopecia, skin pigmentation,and platinum induced neurotoxicity/neuropathy are acceptable for starting on trial, as these toxicities do not preclude treatment with TAS102
  • ECOG Performance Status of 0-2
  • Capacity to understand and sign the informed consent document
  • Able to take medications orally
  • Life expectancy > 12 weeks as predicted by the treating oncologist's clinician judgement
  • Age >18 years
  • Patients of childbearing potential must be using an effective means of contraception including but not limited to barrier methods, birth control, intrauterine devices.

Histologic diagnosis of pancreatic cancer that has been treated previously with one or two lines of chemotherapy.

Previous surgery and/or radiotherapy may have been performed up to 4 weeks prior to the date the subject signs the informed consent form, but there must be evidence of disease progression radiographically or intolerance to first or second-line chemotherapy.

Patients on anticoagulation need to have no evidence of bleeding and be on a stable anticoagulation dose for at least 2 weeks prior to the date the subject signs the informed consent form.

  • 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 signing the informed consent form, 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 3 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.
      • Baseline laboratory values (bone marrow, renal, hepatic) must include:
  • Adequate bone marrow function:

    1. Absolute neutrophil count >1500/µL
    2. Platelet count >75,000/µL
    3. HGB equal to or greater than 7g/dL
  • Renal function:

    a. Serum creatinine ≤ 1.5 mg

  • Hepatic function:

    1. Total bilirubin ≤ 1.5 mg/dL
    2. AST and ALT equal to or less than 3 times the upper limit of normal
    3. Serum calcium ≤ 12 mg/dl

Exclusion Criteria:

  • Pregnant or lactating females
  • Decline using effective means of contraception if sexually active
  • Previously taken TAS-102
  • Myocardial infarction or ischemia within the 6 months before study screening
  • Uncontrolled' clinically significant dysrhythmia
  • No history of an invasive malignancy within the five years prior to initiating therapy on this protocol. Patients may have prior in situ carcinomas (such as of the breast or cervix), non-melanoma skin cancers, Rai Stage 0 chronic lymphocytic leukemia or monoclonal gammopathy of uncertain significance and still otherwise qualify for enrollment on this protocol
  • Radiotherapy to the target lesion within 2 weeks of the date the subject signs the informed consent form
  • Major surgery within 4 weeks of the date the subject signs the informed consent form (the surgical incision should be fully healed prior to study medication administration).
  • Antineoplastic, biologic or anti-cancer treatment within prior 3 weeks. A 3 week washout period will be required prior to beginning study treatment if subjects have received anti-cancer treatment within this time frame.
  • Lingering NCI-CTCAE toxicity grade 2 or higher from prior cancer treatments (excluding alopecia, skin pigmentation, and platinum induced neurotoxicity) > 28 days after the date the subject signs the informed consent form
  • Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications including but not limited to chronic infections, uncontrolled diabetes, congestive heart failure according to the NYHA criteria, untreated brain metastases, liver or renal failure, gastrointestinal hemorrhage.
  • Patients with severe hepatic enzyme impairment manifesting as total bilirubin greater than 1.5 mg/dL or greater than 3 times the upper limit of normal of AST or ALT
  • Known brain metastases or leptomeningeal disease
  • Active infection (i.e., body temperature > or equal to 38-degrees C due to infection)
  • Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
  • 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): NCT02921737


Locations
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United States, Florida
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608
UF Health Cancer Center
Gainesville, Florida, United States, 32608
Tallahasee Memorial HealthCare
Tallahassee, Florida, United States, 32308
Sponsors and Collaborators
University of Florida
Taiho Oncology, Inc.
Investigators
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Principal Investigator: Jennifer M. Duff, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02921737     History of Changes
Other Study ID Numbers: IRB201601319 -A
UF-STO- PANC-003 ( Other Identifier: University of Florida )
IIT-USA-0115 ( Other Identifier: Taiho Oncology )
OCR15253 ( Other Identifier: University of Florida )
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
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
Keywords provided by University of Florida:
metastatic
pancreatic
adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms