Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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

TAS-102

Dennie Jones, MD

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.

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

A Phase II Trial of TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Carcinoma of the Lung

To determine the percentage of subjects who achieve an objective response by RECIST 1.1 criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions. Subjects must have received at least 2 cycles of therapy to be evaluable for this outcome measure.

To determine the percentage of subjects who derive clinical benefit by RECIST 1.1 criteria. The clinical benefit rate is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter 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 1.1 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 overall survival in days

Taiho Oncology, Inc.

University of Florida

Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on days 1 and 15 of each treatment cycle, and 28 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports. The time period over which adverse event data was collected ranged from 165 to 1,095 days.

TAS-102

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

Treatment Arm

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Allison Allegra

Only 2 of the 4 subjects accrued to the study were evaluable for treatment response.

Spots Global Cancer Trial Database for TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial