AzTrials
AzTrials

Small Cell Lung Cancer (SCLC)Phase 2NCT01719861

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

A Phase 2 study testing Desipramine HCL in people with Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors, run by Joel Neal at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Desipramine HCL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Oct 2012to May 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • Received at least one line of prior chemotherapy treatment for metastatic disease.
  • Daily chemotherapy must be completed ≥ 2 weeks prior to registration
  • Weekly chemotherapy must be completed ≥ 2 weeks prior to registration
  • Chemotherapy every 2 weeks must be completed ≥ 3 weeks prior to registration
Show all 24Show fewer
  • Chemotherapy every 3 weeks must be completed ≥ 4 weeks prior to registration
  • ECOG Performance Status 0 to 2
  • Measurable disease by RECIST 1.1 criteria
  • Age at least 18 years
  • Estimated life expectancy at least 3 months
  • Absolute neutrophil count ≥ 1,500/ mm³
  • Platelets ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 mg/dL, OR ≤ 2 X ULN if tumor involves the liver
  • AST(SGOT)
  • ALT(SGPT) ≤ 3 X ULN
  • Creatinine ≤ 1.5 X ULN
  • Creatinine clearance ≥ 45 mL/min/1.73m²) for patients with creatinine levels above institutional normal
  • QT interval corrected using Fridericia's method (QTcF) < 450 msec (males) or < 470 msec (females)
  • PR < 240 msec
  • QRS < 100 msec
  • Brain metastases must be asymptomatic and have been adequately treated with radiation finishing at least 1 week prior to initiation of study treatment.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Clinically-significant ventricular arrhythmia including cardiac arrest
  • Myocardial infarction from coronary artery disease within 3 months of study enrollment
  • Implantable pacemaker or implantable cardioverter defibrillator
  • NYHA Class III or greater congestive heart failure
  • Other clinically-significant cardiac disorders
  • Family history of long QT syndrome.
Show all 19Show fewer
  • Concomitant or expected treatment with strong inhibitors of cytochrome p450 CYP2D6, specifically including Bupropion; Fluoxetine; or Paroxetine (must be discontinued at least 2 weeks or 5-half lives prior to the initiation of desipramine, whichever is shortest, except fluoxetine which requires at least a 5-week washout period).
  • Use of medications known to increase risk of torsades de pointes, including Amiodarone; Arsenic trioxide; Astemizole; Azithromycin; Bepridil; Chloroquine; Chlorpromazine; Cisapride; Citalopram; Clarithromycin; Disopyramide; Dofetilide; Domperidone; Droperidol; Erythromycin; Flecainide; Halofantrine; Haloperidol; Ibutilide; Levomethadyl; Mesoridazine; Methadone; Moxifloxacin; Pentamidine; Pimozide; Probucol; Procainamide; Quinidine; Sotalol; Sparfloxacin; Terfenadine; Thioridazine; Vandetanib
  • Other anti-depressant or anti-psychotic medications including selective serotonin re-uptake inhibitors (SSRIs); other tricyclic, monoamine oxidase inhibitors (MAOIs); serotonin-norepinephrine reuptake inhibitors (SNRIs, typical or atypical anti-psychotic)
  • Metoclopramide (Reglan) because of increased risk of extrapyrimidal symptoms and neuroleptic malignant syndrome
  • Symptomatic orthostatic hypotension despite adequate volume resuscitation.
  • Medical history of narrow angle glaucoma
  • Bipolar disorder, ongoing or active within the last 5 years
  • Suicidal ideation, ongoing or active within the last 5 years
  • Suicide attempt, ongoing or active within the last 5 years
  • Pregnancy
  • Breastfeeding
  • Receiving any other investigational agents
  • Any other serious or unstable concomitant systemic disorder that in the opinion of the investigator is incompatible with the clinical study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University Cancer Institute

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase 2a Intrapatient Dose Escalation Study of Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors

Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.

Read the detailed description

Participants will start desipramine by mouth nightly (QHS) for 6 weeks, with weekly dose escalation. Starting dose will be 25 to 75 mg. The desipramine dose will be escalated until the maximum dose of 450 mg is reached or a maximum safe dose per subject is established.

Dose level may be adjusted (decreased) based on cardiac or general adverse effects. desipramine level will be tapered if the subject experience disease progression, unless physician judges immediate suspension is in the subjects best interest.

Assessments will be conducted every 28 days, and will include ECGs, physicians and blood samples.

One partial and/or complete response will be sufficient to consider a larger clinical trial.

Being tested
Desipramine HCL
Medical subject headings
Small Cell Lung Carcinoma, Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desipramine HCLDrug

    Also called Norpramin, Pertofrane, Desmethylimipramine

    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.

Study groups in NCT01719861
Study groupRoleWhat they receive
Desipramine HClExperimentalDesipramine is a tricyclic antidepressant (TCA).
Receives: Drug: Desipramine HCL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (4)

  1. Desipramine Maximum Dose

    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.

    Measured: Up to 6 weeks

  2. Median Serum Desipramine Levels During Treatment

    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.

    Measured: Up to 6 weeks

  3. Progression-free Survival (PFS), Median

    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.

    Measured: Up to 5 years from enrollment to radiographic progression or drug discontinuation

  4. Median Overall Survival (OS)

    Median overall survival was defined as time from enrollment to death from any cause calculated using the Kaplan-Meier method.

    Measured: From start of enrollment until death, no limit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMay 2014
  4. Study completionMay 2015

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719861
Sponsor's protocol ID
IRB-25491
Other IDs
VAR0087
Status last verified
Mar 2017
First submitted
29 Oct 2012
Last updated
17 Apr 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Desipramine HCL in people with Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors, run by Joel Neal at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01719861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in