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

NCT02921737 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB201601319 -AUF-STO- PANC-003IIT-USA-0115OCR15253
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatic Cancer

Keywords

metastatic; pancreatic; adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  To determine the progression free survival (PFS), which is defined as the duration of time from study entry to disease progression, death, or the date of last contact, whichever occurred first. Subjects were not included in the data for this outcome measure if they went off study for reasons other than disease progression, death or being lost to follow-up.

  up to 54 weeks

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  6 months

• Clinical Benefit Rate

  6 months

• Time to Progression (TTP)

  up to 54 weeks

• Overall Survival (OS)

  up to 84 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

TAS-102

Drug: TAS-102

Interventions

TAS-102 DRUG

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.

Also known as: Lonsurf

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of adenocarcinoma of the pancreas, with pathologic confirmation of adenocarcinoma.
• Measurable disease per RECIST 1.1 criteria
• Metastatic or locally advanced unresectable disease. Subjects without clear evidence of distant metastatic disease will be presented at multidisciplinary tumor board for discussion of disease resectability.
• Refractory or intolerant to 1 or 2 prior regimens of standard chemotherapy for metastatic or locally advanced pancreatic cancer
• 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 at least 12 weeks
• Age at least 18 years
• Patients on anticoagulation need to have no evidence of uncontrolled bleeding and be on a stable anticoagulation dose for at least 2 weeks prior to the date the subject starts study drug.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 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.

You may not qualify if:

• Pregnant or lactating females
• Previously taken TAS-102
• Myocardial infarction or ischemia within the 6 months before first dose of study drug
• Uncontrolled' clinically significant dysrhythmia
• Intervention for ascites or pleural effusions within 4 weeks before first dose of study drug
• Previous surgery and/or radiotherapy may have been performed 2 or more weeks prior to the date the subject starts study treatment, provided that it was to a non-target lesion and there is still evidence of target lesion disease progression radiographically or intolerance to first- or second-line chemotherapy.
• Major surgery within 4 weeks before first dose of study drug (the surgical incision should be fully healed prior to study medication administration).
• Any anticancer therapy within 3 weeks before first dose of study drug.
• Extended field radiation within 4 weeks before first dose of study drug or limited field radiation within 2 weeks before first dose of study drug.
• Any investigational agent received within prior 4 weeks before first dose of study drug
• Subjects must not have more than one active malignancy at the time of enrollment
• Unresolved NCI-CTCAE toxicity grade 2 or higher attributed to any prior therapies (excluding anemia, 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.
• Known untreated or unstable brain metastases or leptomeningeal disease
• Active infection

Sponsors & Collaborators

• University of Florida: lead
• Taiho Oncology, Inc.: collaborator

Study Sites (3)

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

UF Health Cancer Center

Gainesville, Florida, 32608, United States

Location

Tallahasee Memorial HealthCare

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Adenocarcinoma

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Allison Allegra
• Organization: University of Florida

allisonallegra3@ufl.edu

352-294-5691

Study Officials

• Jennifer M. Duff, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 3, 2016
• Study Start: November 9, 2017
• Primary Completion: July 26, 2020
• Study Completion: July 26, 2020
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)