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

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Joel Neal, Stanford University
ClinicalTrials.gov Identifier:
NCT01719861
First received: October 29, 2012
Last updated: March 2, 2017
Last verified: March 2017
Results First Received: January 12, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Small Cell Lung Cancer (SCLC)
Neuroendocrine Tumors
Intervention: Drug: Desipramine HCL

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10 participants total were to be enrolled at Stanford Medical Center between December 2012 - December 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Desipramine HCl 25 mg 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.

Participant Flow for 2 periods

Period 1:   Cycle 1
    Desipramine HCl 25 mg
STARTED   6 
COMPLETED   2 
NOT COMPLETED   4 
Death                4 

Period 2:   Cycle 2
    Desipramine HCl 25 mg
STARTED   2 
COMPLETED   1 
NOT COMPLETED   1 
Death                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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. 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.

Baseline Measures
   Desipramine HCl 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4  66.7% 
>=65 years      2  33.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  33.3% 
Male      4  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  33.3% 
Not Hispanic or Latino      4  66.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1  16.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      5  83.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Histology 
[Units: Participants]
 
Small Cell Carcinoma of Lung   3 
Large Cell Neuroendocrine Carcinoma of Lung   2 
Large Cell Neuroendocrine Carcinoma of Pancreas   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: 6 weeks ]

2.  Secondary:   Desipramine Maximum Dose   [ Time Frame: Up to 6 weeks ]

3.  Secondary:   Median Serum Desipramine Levels During Treatment   [ Time Frame: Up to 6 weeks ]

4.  Secondary:   Progression-free Survival (PFS), Median   [ Time Frame: Up to 5 years from enrollment to radiographic progression or drug discontinuation ]

5.  Secondary:   Median Overall Survival (OS)   [ Time Frame: From start of enrollment until death, no limit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joel Neal, MD, PhD; Assistant Professor of Medicine
Organization: Stanford University Medical Center
phone: 650-725-3081
e-mail: jwneal@stanford.edu



Responsible Party: Joel Neal, Stanford University
ClinicalTrials.gov Identifier: NCT01719861     History of Changes
Other Study ID Numbers: IRB-25491
VAR0087 ( Other Identifier: OnCore )
Study First Received: October 29, 2012
Results First Received: January 12, 2017
Last Updated: March 2, 2017