Trials Sponsors Conditions Drugs Pricing

Conditions

Neuroendocrine Tumors Small Cell Lung Cancer (SCLC)

Outcome Measures

Primary Outcomes (1)

Overall Response Rate (ORR)
Overall response rate (ORR) was assessed as the number of patients who achieve either a partial (PR) or complete response (CR) measured by CT scans and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria, divided by the total number of patients treated on the study. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
6 weeks

Secondary Outcomes (4)

Desipramine Maximum Dose
Up to 6 weeks
Median Serum Desipramine Levels During Treatment
Up to 6 weeks
Progression-free Survival (PFS), Median
Up to 5 years from enrollment to radiographic progression or drug discontinuation
Median Overall Survival (OS)
From start of enrollment until death, no limit

Study Arms (1)

Desipramine HCl

EXPERIMENTAL

Desipramine is a tricyclic antidepressant (TCA).

Drug: Desipramine HCL

Interventions

Desipramine HCLDrug

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.

Also known as: Norpramin, Pertofrane, Desmethylimipramine

Desipramine HCl

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Metastatic small-cell lung cancer
Metastatic high-grade neuroendocrine carcinoma of any organ system (high-grade defined by Ki-67 ≥ 20% and/or ≥ 20 mitoses/10 (HPF).

Sponsors & Collaborators

Joel Neal
Otherlead

Study Sites (1)

Stanford University Cancer Institute

Stanford, California, 94305, United States

MeSH Terms

Conditions

Small Cell Lung CarcinomaNeuroendocrine Tumors

Interventions

Desipramine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and Embryonal

Limitations and Caveats

This study had to be terminated early because patients with small cell lung cancer were not able to tolerate clinically relevant doses of desipramine, and no clinical activity was observed in the first enrolled patients.

Results Point of Contact

Title: Joel Neal, MD, PhD; Assistant Professor of Medicine
Organization: Stanford University Medical Center

Study Officials

Joel W Neal, MD, PhD
Stanford University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

October 29, 2012

First Posted

November 1, 2012

Study Start

October 2012

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Desipramine HCl

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Desipramine HCl

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations