Spots Global Cancer Trial Database for Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors

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Trial Identification

Brief Title: Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors

Official Title: A Phase 2a Intrapatient Dose Escalation Study of Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors

Study ID: NCT01719861

Conditions

Small Cell Lung Cancer (SCLC)

Neuroendocrine Tumors

Interventions

Desipramine HCL

Study Description

Brief Summary: Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.

Detailed Description: Participants will start desipramine by mouth nightly (QHS) for 6 weeks, with weekly dose escalation. Starting dose will be 25 to 75 mg. The desipramine dose will be escalated until the maximum dose of 450 mg is reached or a maximum safe dose per subject is established. Dose level may be adjusted (decreased) based on cardiac or general adverse effects. desipramine level will be tapered if the subject experience disease progression, unless physician judges immediate suspension is in the subjects best interest. Assessments will be conducted every 28 days, and will include ECGs, physicians and blood samples. One partial and/or complete response will be sufficient to consider a larger clinical trial.