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Ectopic ACTH SyndromePhase 2NCT02780882

SOM230 Ectopic ACTH-producing Tumors

A Phase 2 study testing Pasireotide in people with Ectopic ACTH Syndrome, run by Cedars-Sinai Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this prospective open-label phase II study, is to evaluate the efficacy of pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol in patients with ectopic ACTH-producing tumors as measured by the proportion of patients achieving normal UFC at the end of the study… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ectopic ACTH Syndrome
What is being tested?
Pasireotide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2015to Jun 2019
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Written informed consent obtained prior to any screening procedures
  • Male or female patients aged 18 years or greater
  • Confirmed non-pituitary ectopic-ACTH secreting tumor
  • Well differentiated, and low or intermediate grade (WHO classification G1-2) neuroendocrine tumor
  • Tumor size increase < 10% in 6 months prior to screening on CT or MRI
  • Mean 24-hour urinary free cortisol level of at least 1.5 x the upper limit of the normal range, and a morning plasma ACTH level of > 5 ng/L

Who cannot join

  • Patients with highly malignant ACTH-secreting tumors, i.e. small-cell lung carcinomas, medullary thyroid carcinomas, and pheochromocytomas
  • Patients with poorly differentiated neuroendocrine tumors (WHO classification G3)
  • Patients with >10% increase of tumor size in 6 months prior to screening by CT or MRI
  • Patients with Cushing's syndrome due to pituitary ACTH secretion
  • Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
  • Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
Show all 30Show fewer
  • Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
  • Patients who have undergone major surgery within 1 month prior to screening
  • Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
  • Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
  • Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by
  • Congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry
  • QTcF >450 msec at screening
  • History of syncope or family history of idiopathic sudden death
  • Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure
  • Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, concomitant medication(s) known to increase the QT interval
  • Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST more than 2 x ULN, serum creatinine >2.0 x ULN, serum bilirubin >1.5 x ULN, serum albumin < 0.67 x LLN at screening
  • Patients with any ongoing or planned anti-neoplastic therapy
  • Has been treated with radionuclide at any time prior to study entry
  • Is likely to require any additional concomitant treatment to pasireotide for the tumor
  • Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as
  • History of immunocompromise, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical history will be reviewed
  • Presence of active or suspected acute or chronic uncontrolled infection
  • History of, or current alcohol misuse/abuse in the 12 month period prior to screening
  • Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for 3 months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
  • Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with pasireotide
  • Known hypersensitivity to somatostatin analogues
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
  • Patients with presence of Hepatitis B surface antigen (HbsAg)
  • Patients with presence of Hepatitis C antibody test (anti-HCV)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: A Proof of Concept and Open-label Study to Test the Efficacy and Safety of Pasireotide in Patients With Ectopic ACTH-producing Tumors

The purpose of this prospective open-label phase II study, is to evaluate the efficacy of pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol in patients with ectopic ACTH-producing tumors as measured by the proportion of patients achieving normal UFC at the end of the study period.

Being tested
Pasireotide
Keywords
Pasireotide, Ectopic ACTH, SOM230, ectopic ACTH-dependent Cushing's syndrome
Medical subject headings
ACTH Syndrome, Ectopic

What participants receive

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

  • PasireotideDrug

    Also called SOM230

Study groups in NCT02780882
Study groupRoleWhat they receive
PasireotideExperimentalEach patient will be treated with pasireotide at an initial dose of 600 μg twice daily for one month. The dose will be further increased to 900 μg twice daily for month 2 and 3. After month 3, patients who continue to meet the inclusion and exclusion criteria will be entered into an additional 3 months of treatment.
Receives: Drug: Pasireotide

What is being measured

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

  1. Evaluate the efficacy of pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol in patients with ectopic ACTH-producing tumors

    Effectiveness of pasireotide as measured by 24 hour urine free cortisol

    Measured: 6 months

Secondary outcomes (14)

  1. Number of participants with abnormal laboratory values for urine free cortisol

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by urine free cortisol

    Measured: 6 months

  2. Number of participants with abnormal laboratory values for serum cortisol levels

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by serum cortisol levels

    Measured: 6 months

  3. Number of participants with abnormal laboratory values for salivary cortisol levels

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by salivary cortisol levels

    Measured: 6 months

  4. Number of participants with abnormal laboratory values for Hemoglobin A1C (HbA1C)

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by Hemoglobin A1C (HbA1C)

    Measured: 6 months

  5. Number of participants with abnormal laboratory values for fasting blood glucose

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by fasting blood glucose

    Measured: 6 months

  6. Number of participants with abnormal laboratory values for blood electrolytes

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by blood electrolytes

    Measured: 6 months

  7. Number of participants with abnormal laboratory values for plasma adrenocorticotropic hormone (ACTH)

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by plasma adrenocorticotropic hormone (ACTH)

    Measured: 6 months

  8. Number of participants with abnormal laboratory values for plasma beta-lipotropin

    Number of participants with abnormal laboratory values for hormones and metabolism as assessed by plasma beta-lipotropin

    Measured: 6 months

  9. Number of participants with changes in clinical signs and symptoms

    Number of participants with changes in clinical signs and symptoms of Cushing's disease as defined by changes in weight, body mass index, and blood pressure

    Measured: 6 months

  10. Changes in Tumor Size

    To evaluate changes in tumor size

    Measured: From baseline at months 3 and 6

  11. Number of participants with changes in blood chemistry (safety)

    Number of participants with abnormal laboratory values for blood chemistry as assessed by total proteins, amylase, lipase, total cholesterol (TC), low-density lipids (LDL)-cholesterol, m creatinine, creatinine clearance, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, albumin, alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)

    Measured: Baseline and 6 months

  12. Number of participants with changes in hematology (safety)

    Number of participants with abnormal laboratory values for hematology as assessed by prothrombin time (PT), and international normalized ratio (INR)

    Measured: Baseline and 6 months

  13. Number of participants with changes in cardiac activity

    Number of participants with changes in cardiac activity as measured by electrocardiogram (ECG)

    Measured: Baseline and 6 months

  14. Number of participants with changes in liver health

    Number of participants with changes in liver health as determined by an abdominal ultrasound

    Measured: Baseline and 6 months

Timeline

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

  1. First posted24 May 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionJun 2019 (estimated)

Why it stopped: Due to stringent inclusion/exclusion criteria, study investigator deemed it not feasible.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02780882
Sponsor's protocol ID
Pro34493
Status last verified
Jan 2018
First submitted
26 Apr 2016
Last updated
26 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pasireotide in people with Ectopic ACTH Syndrome, run by Cedars-Sinai Medical Center 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 6 inclusion and 30 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: withdrawn, as of the sponsor's last update on 26 Jan 2018. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Evaluate the efficacy of pasireotide twice daily subcutaneous injections for normalizing 24 hour urine free cortisol in patients with ectopic ACTH-producing tumors (time frame: 6 months). 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 NCT02780882.

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 26 Jan 2018.

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