An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects With Poorly Differentiated Neuroendocrine Carcinomas
Overview
- Phase
- Phase 2
- Intervention
- TLC 388
- Conditions
- Neuroendocrine Carcinomas
- Sponsor
- National Health Research Institutes, Taiwan
- Enrollment
- 23
- Locations
- 7
- Primary Endpoint
- the objective response rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Title of Study:
An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects with Poorly Differentiated Neuroendocrine Carcinomas
Investigational product:
Lipotecan®*
*Lipotecan® is the trade name of TLC388 HCl, a Topoisomerase I inhibitor)
Phase of development:
Phase II
Number of subjects:
Plan to enroll 44 subjects
Objectives:
Primary objectives:
To determine the objective response rate
Secondary objectives:
To evaluate Disease control rate, Progression free survival, Overall survival, Safety profile and Biomarkers
Detailed Description
This is a phase II, open-label, single-arm, two-stage, multicenter study to evaluate the efficacy and safety of Lipotecan® monotherapy in subjects with poorly differentiated neuroendocrine carcinomas. Only those subjects who have failed to first line chemotherapy (Etoposide plus platinum) due to treatment intolerance or radiographic progressive disease (PD), as per RECIST v1.1, are eligible to participate in the study. The scheduled assessments should be performed as identified on a calendar schedule, and should not be affected by delays in therapy, drug holidays or any other events that might be lead to imbalance in a treatment arm in the timing of disease assessment. Efficacy results are based on radiographic assessments reviewed by the investigator. Eligible subjects will receive 40 mg/m2 of Lipotecan®, given as a 30 (+3) minute intravenous infusion, on Days 1, 8 and 15 of a 28-day cycle until PD, unacceptable toxicity or consent withdrawal occurs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed poorly differentiated neuroendocrine carcinomas.
- •Patients who had first-line treatment failure (First line therapy must be etoposide plus platinum) due to treatment intolerance or radiographic progressive disease (as per RECIST v1.1).
- •At least one measurable lesion in a non-irradiated area.
- •Aged \> 20 years old.
- •ECOG Performance Status ≤
- •Life expectancy greater than 12 weeks.
- •Adequate bone marrow function :
- •absolutely neutrophil count ≥ 1500 /mm3 or WBC ≥ 4000/mm3
- •Hemoglobin \> 9 g/dl
- •platelet count ≥ 100,000 /mm3
Exclusion Criteria
- •Major surgery within two weeks prior to entering the study.
- •Patients with CNS metastasis, including clinical suspicion.
- •Patients who are under active or uncontrolled infections.
- •Patients with concomitant illness that might be aggravated by chemotherapy.
- •Patients who are pregnant or with breast feeding.
- •Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
- •Fertile men and women unless using a reliable and appropriate contraceptive method
- •A history of or the presence of one or more cardiac diseases, such as congestive heart failure (New York Heart Association Class III or IV), myocardial infarction or unstable angina and related surgeries, within 3 months prior to the initiation of the treatment dose.
- •Patients with a known history of human immunodeficiency virus infection.
- •The presence of active or uncontrolled systemic infection (bacterial, viral, other) except for chronic hepatitis B and hepatitis C.
Arms & Interventions
Assigned Interventions
TLC 388
Intervention: TLC 388
Outcomes
Primary Outcomes
the objective response rate
Time Frame: 5 years
Analysis for the objective response rate will be conducted on both the per protocol(PP) and evaluable data sets.
Secondary Outcomes
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(5 years)
- Progression free survival(5 years)
- Disease control rate(5 years)
- Overall survival(5 years)