Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Disease Progression

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

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.

TAS-102

Jennifer M. Duff, MD

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.

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

A Phase II Trial of TAS-102 (Lonsurf) in Patients With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma After Progression Through First Line Chemotherapy

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.

To determine the objective response rate (ORR) by RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 criteria. ORR is defined as the percentage of subjects who attained either a complete or partial response (CR + PR) by RECIST v1.1 criteria. RECIST v1.1 criteria defines a partial response (PR) as a decrease of the sum of the largest diameters of each target lesion by at least 30%. A complete response (CR) is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less).

To determine the Clinical Benefit Rate, defined as the percent of evaluable subjects who achieved either a complete or partial response or stable disease per RECIST v1.1 criteria. RECIST v1.1 criteria defines a partial response as a decrease of the sum of the largest diameter of each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST v1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.

To determine the time to progression (TTP), defined as the duration of time from study entry to disease progression

To determine overall survival (OS), defined as the duration of time from study entry to time of death.

Taiho Oncology, Inc.

University of Florida

Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at screening, on day 1 of each treatment cycle, and up to 30 days after the last dose of study treatment at a minimum, for up to 414 days. Adverse events were assessed by physical examination, labs, and subject self-reports.

TAS-102

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.

Spots Global Cancer Trial Database for TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial