Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
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ClinicalTrials.gov Identifier: NCT01719861 |
Recruitment Status :
Terminated
(Lack of efficacy)
First Posted : November 1, 2012
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
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Sponsor:
Joel Neal
Information provided by (Responsible Party):
Joel Neal, Stanford University
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Small Cell Lung Cancer (SCLC) Neuroendocrine Tumors |
Intervention |
Drug: Desipramine HCL |
Enrollment | 6 |
Participant Flow
Recruitment Details | 10 participants total were to be enrolled at Stanford Medical Center between December 2012 - December 2013 |
Pre-assignment Details |
Arm/Group Title | Desipramine HCl 25 mg |
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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. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects. |
Period Title: Cycle 1 | |
Started | 6 |
Completed | 2 |
Not Completed | 4 |
Reason Not Completed | |
Death | 4 |
Period Title: Cycle 2 | |
Started | 2 |
Completed | 1 |
Not Completed | 1 |
Reason Not Completed | |
Death | 1 |
Baseline Characteristics
Arm/Group Title | Desipramine HCl | |
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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. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects. | |
Overall Number of Baseline Participants | 6 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
4 66.7%
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>=65 years |
2 33.3%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
Female |
2 33.3%
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Male |
4 66.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
Hispanic or Latino |
2 33.3%
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Not Hispanic or Latino |
4 66.7%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
1 16.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
5 83.3%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Histology
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 6 participants |
Small Cell Carcinoma of Lung | 3 | |
Large Cell Neuroendocrine Carcinoma of Lung | 2 | |
Large Cell Neuroendocrine Carcinoma of Pancreas | 1 |
Outcome Measures
Adverse Events
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.
More Information
Results Point of Contact
Name/Title: | Joel Neal, MD, PhD; Assistant Professor of Medicine |
Organization: | Stanford University Medical Center |
Phone: | 650-725-3081 |
EMail: | jwneal@stanford.edu |
Responsible Party: | Joel Neal, Stanford University |
ClinicalTrials.gov Identifier: | NCT01719861 |
Other Study ID Numbers: |
IRB-25491 VAR0087 ( Other Identifier: OnCore ) |
First Submitted: | October 29, 2012 |
First Posted: | November 1, 2012 |
Results First Submitted: | January 12, 2017 |
Results First Posted: | April 17, 2017 |
Last Update Posted: | April 17, 2017 |