Trial Outcomes & Findings for TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003) (NCT NCT02921737)

Last Updated: 2021-02-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

up to 54 weeks

Results posted on

2021-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm 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.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=7 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 54 weeks

Population: Only 6 subjects met the criteria to be included in the data for this endpoint.

Outcome measures

Outcome measures
Measure	Treatment Arm n=6 Participants 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.
Progression Free Survival (PFS)	13.64 weeks Interval 0.14 to 53.86

SECONDARY outcome

Timeframe: 6 months

Population: Only two subjects were considered evaluable for this outcome measure.

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).

Outcome measures

Outcome measures
Measure	Treatment Arm n=2 Participants 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.
Objective Response Rate (ORR)	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Only two subjects were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Treatment Arm n=2 Participants 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.
Clinical Benefit Rate	1 Participants

SECONDARY outcome

Timeframe: up to 54 weeks

Population: Disease progression only occurred for 5 subjects.

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=5 Participants 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.
Time to Progression (TTP)	15.43 weeks Interval 0.14 to 53.86

SECONDARY outcome

Timeframe: up to 84 weeks

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

Outcome measures

Outcome measures
Measure	Treatment Arm n=7 Participants 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.
Overall Survival (OS)	23.45 weeks Interval 4.71 to 83.29

Adverse Events

Treatment Arm

Serious events: 2 serious events

Other events: 6 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm n=7 participants at risk 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.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders Abdominal distension	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.

Other adverse events

Other adverse events
Measure	Treatment Arm n=7 participants at risk 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.
Gastrointestinal disorders Abdominal pain	42.9% 3/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Investigations Alkaline phophatase increased	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
General disorders Chills	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders Constipation	28.6% 2/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders Diarrhea	42.9% 3/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Nervous system disorders Dizziness	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
General disorders Edema limbs	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
General disorders Fatigue	71.4% 5/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
General disorders Fever	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders Flatulence	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders Gastroesophageal reflux disease	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders diverticulitis	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders Nausea	42.9% 3/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Investigations Neutrophil count decreased	57.1% 4/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Respiratory, thoracic and mediastinal disorders Postnasal drip	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Gastrointestinal disorders Vomiting	28.6% 2/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.
Investigations White blood cell count decreased	14.3% 1/7 • Adverse event data were collected at screening, on day 1 of each cycle, and up to 30 days after the last dose of study drug at a minimum, for up to 414 days. 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.

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place