Trial Outcomes & Findings for Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors (NCT NCT01719861)
NCT ID: NCT01719861
Last Updated: 2017-04-17
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-04-17
Participant Flow
10 participants total were to be enrolled at Stanford Medical Center between December 2012 - December 2013
Participant milestones
| Measure |
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.
|
|---|---|
|
Cycle 1
STARTED
|
6
|
|
Cycle 1
COMPLETED
|
2
|
|
Cycle 1
NOT COMPLETED
|
4
|
|
Cycle 2
STARTED
|
2
|
|
Cycle 2
COMPLETED
|
1
|
|
Cycle 2
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Cycle 1
Death
|
4
|
|
Cycle 2
Death
|
1
|
Baseline Characteristics
Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Desipramine HCl
n=6 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Histology
Small Cell Carcinoma of Lung
|
3 participants
n=5 Participants
|
|
Histology
Large Cell Neuroendocrine Carcinoma of Lung
|
2 participants
n=5 Participants
|
|
Histology
Large Cell Neuroendocrine Carcinoma of Pancreas
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: All patients who were enrolled and started therapy.
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.
Outcome measures
| Measure |
Desipramine HCl 25 mg
n=6 Participants
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 Response Rate (ORR)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 weeksPopulation: All patients who were enrolled and started therapy.
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.
Outcome measures
| Measure |
Desipramine HCl 25 mg
n=6 Participants
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.
|
|---|---|
|
Desipramine Maximum Dose
|
75 mg daily
Interval 75.0 to 300.0
|
SECONDARY outcome
Timeframe: Up to 6 weeksPopulation: All patients who were enrolled and started therapy.
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.
Outcome measures
| Measure |
Desipramine HCl 25 mg
n=6 Participants
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.
|
|---|---|
|
Median Serum Desipramine Levels During Treatment
|
132 ng/mL
Interval 0.0 to 490.0
|
SECONDARY outcome
Timeframe: Up to 5 years from enrollment to radiographic progression or drug discontinuationPopulation: All patients who were enrolled and started therapy.
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.
Outcome measures
| Measure |
Desipramine HCl 25 mg
n=6 Participants
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.
|
|---|---|
|
Progression-free Survival (PFS), Median
|
1.2 Months
Interval 0.2 to 3.3
|
SECONDARY outcome
Timeframe: From start of enrollment until death, no limitPopulation: All patients who were enrolled and started therapy.
Median overall survival was defined as time from enrollment to death from any cause calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Desipramine HCl 25 mg
n=6 Participants
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.
|
|---|---|
|
Median Overall Survival (OS)
|
2.7 Months
Interval 1.3 to 5.6
|
Adverse Events
Desipramine HCl 25 mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Desipramine HCl 25 mg
n=6 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Death
|
83.3%
5/6 • Number of events 5 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Rectal Obstruction
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
Other adverse events
| Measure |
Desipramine HCl 25 mg
n=6 participants at risk
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.
|
|---|---|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 2 • Cycle 1 (28 days)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Skin and subcutaneous tissue disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 2 • Cycle 1 (28 days)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
2/6 • Number of events 2 • Cycle 1 (28 days)
|
|
Renal and urinary disorders
Renal and urinary disorders, Other - polyuria
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Renal and urinary disorders
Renal and urinary disorders, - nocturia
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
General disorders
General disorders, Other - night sweats
|
50.0%
3/6 • Number of events 3 • Cycle 1 (28 days)
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Number of events 2 • Cycle 1 (28 days)
|
|
Investigations
ALT increased
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Investigations
AST increased
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Rectal Pain
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3 • Cycle 1 (28 days)
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 3 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Psychiatric disorders
Confusion
|
33.3%
2/6 • Number of events 2 • Cycle 1 (28 days)
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Cycle 1 (28 days)
|
|
Cardiac disorders
Palpitation
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 3 • Cycle 1 (28 days)
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6 • Number of events 2 • Cycle 1 (28 days)
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 3 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Gastrointestinal disorders
Gastrointestional disorders, other - Black stools
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Psychiatric disorders
Hallucinations
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • Cycle 1 (28 days)
|
Additional Information
Joel Neal, MD, PhD; Assistant Professor of Medicine
Stanford University Medical Center
Phone: 650-725-3081
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place