Small Cell Lung Cancer Clinical Trial
Official title:
A Phase IIa Intrapatient Dose Escalation Study of Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
Intrapatient dose escalation of desipramine. Start at 75 mg daily. Increase by 75 mg weekly to maximum of 450 mg daily. Taper desipramine upon disease progression, unacceptable toxicity or patient withdrawal from study.
Primary Objective:
To determine the overall response rate (ORR) of small cell lung cancer and high-grade
neuroendocrine tumors in patients during treatment with desipramine.
Secondary Objectives:
- To determine the progression-free survival (PFS) and overall survival (OS).
- To perform exploratory blood biomarker analysis of PCSK1 and ROBO1 in patients enrolled
on this trial.
- To measure safety of desipramine using type, frequency and severity of adverse event
reactions reported according to CTCAE v4.0
- To measure tolerability using the incidence of adverse events (AEs) leading to
desipramine delay or discontinuation
- To establish the MTD of desipramine in each patient by adhering to an intrapatient dose
escalation schema
- To measure serum desipramine levels during treatment
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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