ClinicalTrials.gov

History of Changes for Study: NCT02921737
TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003)
Latest version (submitted January 13, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 September 29, 2016 None (earliest Version on record)
2 December 9, 2016 Study Status
3 January 11, 2017 Study Status and Study Identification
4 January 31, 2017 Study Status, Oversight, IPDSharing and Study Identification
5 March 6, 2017 Study Status and Study Identification
6 March 30, 2017 Study Status and Study Identification
7 April 4, 2017 Study Status and Study Identification
8 April 10, 2017 Oversight and Study Status
9 May 30, 2017 Study Status
10 June 30, 2017 Study Status
11 August 1, 2017 Study Status
12 August 24, 2017 Eligibility, Oversight, Study Status and Study Identification
13 September 6, 2017 Study Status
14 September 14, 2017 Eligibility, Outcome Measures, Arms and Interventions and Study Status
15 October 2, 2017 Recruitment Status, Study Status and Contacts/Locations
16 October 4, 2017 Study Status
17 November 6, 2017 Study Status
18 November 17, 2017 Study Status
19 December 14, 2017 Study Status and Study Design
20 January 18, 2018 Contacts/Locations and Study Status
21 May 24, 2018 Contacts/Locations, Study Status, Eligibility and Outcome Measures
22 June 27, 2018 Study Status, Eligibility and Study Description
23 August 6, 2018 Study Status and Study Design
24 August 30, 2018 Contacts/Locations and Study Status
25 December 24, 2018 Study Status and Study Identification
26 December 27, 2018 Study Status and Study Identification
27 January 2, 2019 Contacts/Locations and Study Status
28 January 11, 2019 Study Status and Study Identification
29 June 19, 2019 Study Status and Contacts/Locations
30 August 7, 2019 Recruitment Status, Study Status and Contacts/Locations
31 August 16, 2019 Study Status
32 October 3, 2019 Study Status
33 February 20, 2020 Recruitment Status, Study Status, Study Design and Eligibility
34 August 4, 2020 Recruitment Status and Study Status
35 December 15, 2020
Quality Control Review has not concluded Returned: January 8, 2021
Outcome Measures, Study Status, Documents
36 January 13, 2021 Reported Adverse Events, Outcome Measures, Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02921737
Submitted Date:  September 14, 2017 (v14)

Study Identification
Unique Protocol ID: IRB201601319
Brief Title: TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003)
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
Secondary IDs: UF-STO- PANC-003 [University of Florida]
IIT-USA-0115 [Taiho Oncology]
15253 [University of Florida]
Study Status
Record Verification: September 2017
Overall Status: Not yet recruiting
Study Start: October 1, 2017
Primary Completion: October 1, 2019 [Anticipated]
Study Completion: October 1, 2020 [Anticipated]
First Submitted: September 26, 2016
First Submitted that
Met QC Criteria:
September 29, 2016
First Posted: October 3, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 14, 2017
Last Update Posted: September 15, 2017 [Actual]
Sponsor/Collaborators
Sponsor: University of Florida
Responsible Party: Sponsor
Collaborators: Taiho Oncology, Inc.
Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Study Description
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 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.
Detailed Description:
Conditions
Conditions: Pancreatic Cancer
Keywords: metastatic
pancreatic
adenocarcinoma
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 33 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
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 Names:
  • Lonsurf
Outcome Measures
Primary Outcome Measures:
1. Progression Free Survival (PFS)
To determine the progression free survival (PFS)

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

[Time Frame: 6 months]
3. Clinical Benefit Rate
To determine the Clinical Benefit Rate (objective response + disease stability rate)

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

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

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

[Time Frame: 6 months]
7. Drug Compliance Diary
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

[Time Frame: 6 months]
Eligibility
Minimum Age: 18 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
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.
  • Documented progression or intolerance to first line chemotherapy.
  • TAS102 will be planned to start after disease progression on first-line chemotherapy, provided any prior chemotherapy-related toxicities have resolved to less than or equal to Grade 1 or baseline. 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 line of chemotherapy.

Previous surgery and/or radiotherapy could have been performed up to one month prior to study enrollment, but there must be evidence of disease progression radiographically or intolerance to first-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 trial enrollment

  • 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 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
  • Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study medication administration).
  • Antineoplastic, biologic or anti-cancer treatment within prior 3 weeks
  • Lingering NCI-CTCAE toxicity grade 2 or higher from prior cancer treatments (excluding alopecia, skin pigmentation, and platinum induced neurotoxicity)
  • 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
Contacts/Locations
Central Contact: Alisha J. Daniels, MD,MHA
Telephone: (352) 294-8568
Email: alisha.daniels@ufl.edu
Central Contact Backup: Allison B. Trainor, MPH
Email: awickham@ufl.edu
Study Officials: Jennifer M. Duff, MD
Principal Investigator
University of Florida
Locations: United States, Florida
UF Health Cancer Center
Gainesville, Florida, United States, 32608
Contact: Allison B. Trainor, MPH awickham@ufl.edu
IPDSharing
Plan to Share IPD: No
References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services