NCT01719861

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Joel Neal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Cell Lung Cancer (SCLC)
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Desipramine HCL	Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. The target dose level at 6 weeks is 450 mg (maximum dosage) or the maximum tolerated dose (MTD) for each subject.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-05-01
• Completion: 2015-05-01
• First posted: 2012-11-01
• Last updated: 2017-04-17
• Results posted: 2017-04-17

Locations

1 site across 1 country: United States