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Anti-metabolites

All patients- TAS-102 for Neuroendocrine Carcinoma (TAS-102 NEC Trial)

Phase 2
Waitlist Available
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

TAS-102 NEC Trial Summary

This trial is testing the safety and efficacy of drug TAS-102 in treating patients with extrapulmonary high-grade neuroendocrine cancer. TAS-102 has demonstrated improved survival and tolerability in patients with colorectal cancer and is currently approved by the FDA. Recently, a study showed a case of complete remission of high-grade NEC with TAS-102, so the trial is testing if TAS-102 is tolerable and effective in neuro-endocrine cancer patients.

Eligible Conditions
  • High-grade Extra Pulmonary Neuroendocrine Carcinoma

TAS-102 NEC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Overall Survival (OS)
Progression free survival (PFS)

Side effects data

From 2023 Phase 3 trial • 492 Patients • NCT04737187
62%
Neutropenia
37%
Nausea
28%
Anaemia
24%
Asthenia
22%
Fatigue
21%
Diarrhoea
20%
Decreased appetite
18%
Vomiting
17%
Thrombocytopenia
14%
Neutrophil count decreased
11%
Constipation
11%
Stomatitis
11%
Abdominal pain
10%
Hypertension
9%
Abdominal pain upper
9%
Platelet count decreased
9%
Aspartate aminotransferase increased
9%
Alanine aminotransferase increased
8%
Weight decreased
8%
Headache
7%
Leukopenia
7%
Arthralgia
7%
Back pain
6%
Proteinuria
5%
Blood bilirubin increased
5%
Pyrexia
3%
Intestinal obstruction
2%
Malignant neoplasm progression
2%
COVID-19
1%
Hyperbilirubinaemia
1%
Acute kidney injury
1%
Biliary dilatation
1%
Large intestinal obstruction
1%
Stoma site haemorrhage
1%
Septic shock
1%
Metastases to meninges
1%
Jaundice
1%
Bile duct stenosis
1%
Cholangitis
1%
Jaundice cholestatic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trifluridine/Tipiracil + Bevacizumab
Trifluridine/Tipiracil

TAS-102 NEC Trial Design

1Treatment groups
Experimental Treatment
Group I: TAS-102Experimental Treatment1 Intervention
Patients will receive TAS-102, Orally, BID for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest treatment cycle. Treatment may continue until disease progresses, intolerable toxicity is developed, or if the patient becomes pregnant or dies.

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,407 Total Patients Enrolled
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,570 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does TAS-102 pose any risks to human health?

"Our team at Power gave All patients-TAS-102 a safety ranking of 2, as this Phase 2 trial has only seen some evidence for its security rather than any proof of efficacy."

Answered by AI

Has this clinical trial been pioneered in the past?

"As of now, 43 open studies concerning All patients- TAS-102 are available across 28 nations and 235 cities. This drug was first tested in 2017 by Taiho Oncology, Inc., to determine its effectiveness via a Phase 1 & 2 trial involving 56 participants. Since then, 27 other trials have concluded."

Answered by AI

What therapeutic purpose does All patients- TAS-102 typically serve?

"Commonly, vaccinia-related lesions in the cornea and conjunctiva are managed using All patients- TAS-102. This medication is also efficacious at treating other ocular issues such as blepharitis or conditions that have been previously treated with oxaliplatin chemotherapy or anti-VEGF agents."

Answered by AI

Are there any precedent research studies that have examined the effects of TAS-102 on all patients?

"At the moment, there are 43 ongoing trials for All patients- TAS-102. Out of these, 4 studies have reached phase 3. The majority of such clinical tests take place in Lakewood, New jersey; however, 527 other locations also offer this medication as part of a study or trial."

Answered by AI

Is this research endeavor open to new enrollees?

"Affirmative. Clinicaltrials.gov states that this clinical trial is actively recruiting patients, having been first posted on August 15th 2019 with the most recent update being made in January 16th 2020. 14 individuals are required to be recruited from 1 medical facility."

Answered by AI

How many individuals are currently participating in this trial?

"Affirmative. Clinicaltrials.gov verifies that this study, which was initially published on August 15th 2019, is presently searching for participants. In total, 14 patients must be enlisted from a single clinical site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Baylor Scott and White University Medical Center,
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
TAS-102 in Extrapulmonary Neuroendocrine Carcinoma
2019. "TAS-102 in Extrapulmonary Neuroendocrine Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04042714.
~2 spots leftby Apr 2025
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