Status:
TERMINATED
TAS-102 in Extrapulmonary Neuroendocrine Carcinoma
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Taiho Oncology, Inc.
Conditions:
High-grade Extra Pulmonary Neuroendocrine Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the safety and efficacy of drug, TAS-102 (trifluridine/tipiracil), in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer. TAS-102 dem...
Detailed Description
Neuroendocrine tumors are highly prevalent cancer showing heterogeneous array of behaviors. For intermediate/high grade and poorly differentiated neuroendocrine carcinomas (NEC) that occur outside the...
Eligibility Criteria
Inclusion
- Pathologic confirmation of high grade NEC using WHO criteria as determined by Ki67\>20%, poorly differentiated (G3) characteristics, or \>20 mitotic figures/10 high-power fields.
- Unknown primary may be included. Suspected extrapulmonary patients with known lung primary will be excluded.
- Prior treatment with a platinum containing regimen
- RECIST 1.1 measurable disease
- Evidence of stage IV, metastatic disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Serum albumin ≥2.5 gm/dL.
- Expected survival ≥3 months.
- Adequate hematologic function as defined by: a) Absolute neutrophil count (ANC) \>1500/mm3; b) Platelets ≥75,000/mm3; c) Hemoglobin \>8 g/dL (in the absence of red blood transfusion).
- Adequate liver function, as defined by: a) Serum total bilirubin ≤2.5 x ULN mg/dL. b) ALT (SGPT) and AST (SGOT) ≤5 x upper limit of normal (ULN).
- Adequate renal function, as defined by serum creatinine ≤2.0 x ULN, or creatinine clearance ≥30 mL/min
- Females of child bearing potential must agree to use contraception to avoid pregnancy throughout the study.
Exclusion
- Women who are pregnant or breastfeeding.
- Evidence of low-grade or well-differentiated features as determined by the investigator.
- Functional neuroendocrine tumors are excluded.
- Known pulmonary primary or small cell lung cancer will be excluded.
- Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last six months.
- Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38°C).
- Other severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: a) Severe impaired lung functions as defined by spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air, b) Uncontrolled diabetes,c) Liver disease such as cirrhosis or severe hepatic impairment, d) Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the integrity of the study.
- Taking other investigational or anti-cancer treatments while participating in this study. Concurrent radiotherapy is allowed provided to non-target lesions. If target lesions have received radiation therapy, progression must have been demonstrated prior to enrollment.
- Prior or concurrent malignancy, except for the following: a) Adequately treated basal cell or squamous cell skin cancer; b) Cervical carcinoma in situ; c) Adequately treated Stage I or II cancer from which the subject is currently in complete remission; d) Or any other cancer from which the subject has been disease-free for 3 years.
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04042714
Start Date
August 15 2019
End Date
October 15 2025
Last Update
November 4 2025
Active Locations (1)
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1
Baylor Scott and White University Medical Center,
Dallas, Texas, United States, 75246