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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Joel Neal, Stanford University

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Desipramine HCl
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  66.7%
>=65 years
2
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
2
  33.3%
Not Hispanic or Latino
4
  66.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 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  
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
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were enrolled and started therapy.
Arm/Group Title Desipramine HCl 25 mg
Hide Arm/Group Description:
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 Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Secondary Outcome
Title Desipramine Maximum Dose
Hide Description Assessed as the median per patient maximum dose (MD) using intra-patient dose escalation, and reported as the highest dose of desipramine administered continuously for 1 week or greater.
Time Frame Up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were enrolled and started therapy.
Arm/Group Title Desipramine HCl
Hide Arm/Group Description:
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 Participants Analyzed 6
Median (Full Range)
Unit of Measure: mg daily
75
(75 to 300)
3.Secondary Outcome
Title Median Serum Desipramine Levels During Treatment
Hide Description

Median serum desipramine levels during treatment is reported as the median of the maximum steady state serum concentration observed in all patients.

Therapeutic concentration of desipramine is 100 to 300 ng/mL, and toxic concentration is > 300 ng/mL.
Time Frame Up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were enrolled and started therapy.
Arm/Group Title Desipramine HCl
Hide Arm/Group Description:
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 Participants Analyzed 6
Median (Full Range)
Unit of Measure: ng/mL
132
(0 to 490)
4.Secondary Outcome
Title Progression-free Survival (PFS), Median
Hide Description Median PFS was defined as the time from randomization to disease progression (or death if the patient died before progression) calculated using the Kaplan-Meier method.
Time Frame Up to 5 years from enrollment to radiographic progression or drug discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were enrolled and started therapy.
Arm/Group Title Desipramine HCl
Hide Arm/Group Description:
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 Participants Analyzed 6
Median (Full Range)
Unit of Measure: Months
1.2
(0.2 to 3.3)
5.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description Median overall survival was defined as time from enrollment to death from any cause calculated using the Kaplan-Meier method.
Time Frame From start of enrollment until death, no limit
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were enrolled and started therapy.
Arm/Group Title Desipramine HCl
Hide Arm/Group Description:
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 Participants Analyzed 6
Median (Full Range)
Unit of Measure: Months
2.7
(1.3 to 5.6)
Time Frame Cycle 1 (28 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desipramine HCl 25 mg
Hide Arm/Group Description 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.
All-Cause Mortality
Desipramine HCl 25 mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Desipramine HCl 25 mg
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  1/6 (16.67%)  1
Gastrointestinal disorders   
Rectal Obstruction * 1  1/6 (16.67%)  1
Injury, poisoning and procedural complications   
Death * 1  5/6 (83.33%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Desipramine HCl 25 mg
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  3/6 (50.00%)  3
Cardiac disorders   
Sinus tachycardia * 1  1/6 (16.67%)  1
Palpitation * 1  1/6 (16.67%)  1
Gastrointestinal disorders   
Abdominal pain * 1  2/6 (33.33%)  2
Rectal Pain * 1  1/6 (16.67%)  1
Constipation * 1  3/6 (50.00%)  3
Dry mouth * 1  1/6 (16.67%)  1
Nausea * 1  2/6 (33.33%)  3
Vomiting * 1  1/6 (16.67%)  1
Gastrointestional disorders, other - Black stools * 1  1/6 (16.67%)  1
General disorders   
Fatigue * 1  3/6 (50.00%)  3
General disorders, Other - night sweats * 1  3/6 (50.00%)  3
Non-cardiac chest pain * 1  1/6 (16.67%)  1
Investigations   
ALT increased * 1  1/6 (16.67%)  1
AST increased * 1  1/6 (16.67%)  1
Weight loss * 1  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Hypokalemia * 1  1/6 (16.67%)  1
Anorexia * 1  3/6 (50.00%)  3
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/6 (33.33%)  2
Pain in extremity * 1  1/6 (16.67%)  1
Generalized muscle weakness * 1  1/6 (16.67%)  1
Nervous system disorders   
Dysgeusia * 1  1/6 (16.67%)  1
Dizziness * 1  1/6 (16.67%)  1
Lethargy * 1  1/6 (16.67%)  1
Dysarthria * 1  1/6 (16.67%)  1
Tremor * 1  1/6 (16.67%)  1
Headache * 1  2/6 (33.33%)  2
Amnesia * 1  1/6 (16.67%)  1
Psychiatric disorders   
Confusion * 1  2/6 (33.33%)  2
Insomnia * 1  2/6 (33.33%)  2
Hallucinations * 1  1/6 (16.67%)  1
Anxiety * 1  1/6 (16.67%)  1
Renal and urinary disorders   
Urinary retention * 1  2/6 (33.33%)  2
Renal and urinary disorders, Other - polyuria * 1  1/6 (16.67%)  1
Renal and urinary disorders, - nocturia * 1  1/6 (16.67%)  1
Dysuria * 1  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular * 1  1/6 (16.67%)  1
Dry mouth * 1  1/6 (16.67%)  1
Vascular disorders   
Hypertension * 1  2/6 (33.33%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
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
Layout table for Results Point of Contact information
Name/Title: Joel Neal, MD, PhD; Assistant Professor of Medicine
Organization: Stanford University Medical Center
Phone: 650-725-3081
EMail: jwneal@stanford.edu
Layout table for additonal information
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