COR-003 Clinical Trial for Cushing’s Syndrome

CureClick_Trial_Card_CushingsBLU2

 

This trial is testing the safety and effectiveness of an investigational drug for the treatment of Cushing’s Syndrome. Under the supervision of qualified physicians, cortisol levels and symptoms of Cushing’s Syndrome will be closely followed along with any signs of side effects.

More about the study:

The study drug (COR-003) is administered by tablets.

  • There will be 90 participants in this trial
  • There is no placebo used in the trial

If you are interested, please find the full study details and eligibility criteria listed here.

Eligibility Criteria:

Participants must:

  • be at least 18 years old
  • have been diagnosed with endogenous Cushing’s Syndrome by a medical professional (not caused by the use of steroid medications)

Participants must not:

  • have been treated with radiation for Cushing’s Syndrome in the past 4 years
  • be currently using weight loss medication
  • have been diagnosed with uncontrolled hypertension, some forms of cancer, adrenal carcinoma, Hepatitis B / C, or HIV

Please complete the online questionnaire to check if you’re eligible for the trial.

If you’re not familiar with clinical trials, here are some FAQs:

What are clinical trials?

Clinical trials are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All new investigational medications and devices must undergo several clinical trials, often involving thousands of people.

Why participate in a clinical trial?

You will have access to investigational treatments that would be available to the general public only upon approval. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

Learn why I’m posting about this Clinical Trial

Clinical Trial for levoketoconazole

This trial is testing the safety and effectiveness of a new investigational drug for the treatment of Cushing’s Syndrome. Under the supervision of qualified physicians, cortisol levels and symptoms of Cushing’s Syndrome will be closely followed along with any signs of side effects.

The investigational drug (levoketoconazole) is administered by mouth in the form of tablets.

This is a phase 3 trial.

There will be up to 90 participants worldwide in this trial. This page lists U.S. sites only.

Eligibility criteria

Participants must:

be at least 18 years old
have been diagnosed with endogenous Cushing’s Syndrome by a medical professional (endogenous means that it is caused by your body producing more cortisol than it needs, not caused by the use of steroid medications)
Participants must not:

have been treated with radiation for their endogenous Cushing’s syndrome in the past 4 years
be currently using weight loss medication
have a history of drug or alcohol abuse
have been diagnosed with uncontrolled hypertension, some forms of cancer, adrenal carcinoma, Hepatitis B / C, or HIV
Note: The study doctor will ultimately determine your eligibility
Study details

The length of this study and the number of study visits will vary from patient to patient. It has approximately 13 to 27 visits to the study site spread out over one to one and a half years. This study will enroll approximately 90 participants.

A placebo isn’t being used for this trial. All study participants will receive the investigational drug.

The sponsor of this trial is Cortendo AB.

The results of this trial are intended to be published. Individual patient information will not be included.

Reasonable travel expenses may be reimbursed.

This is a global study which will be conducted in multiple countries, with several sites in the US.

This information is intended for US audiences only.

Find out if you’re eligible here.

An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome

RESEARCH STUDY SUMMARY

An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome

PURPOSE

The primary objectives of this study are to evaluate the efficacy of ascending doses of COR-003 in subjects with elevated levels of cortisol due to endogenous Cushing’s Syndrome by assessment of reduction in Urinary Free Cortisol (UFC) concentrations and to identify the range of safe and effective doses of COR-003 that reduce mean UFC concentrations ≤ULN (upper limit of normal) of the assay at month 6 of the maintenance phase of dosing without a prior dose increase in that phase.

TO LEARN MORE

CW ID: 208654
Date Last Changed: June 25, 2015

Inclusion Criteria:

Subjects eligible for enrollment in the study must meet all the following criteria:

  • Male or female, ≥18 year of age
  • Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if they are not candidates for surgery. Subjects in whom surgery will be delayed beyond 5 months will be permitted to participate. CS will be defined according to the criteria in the guidelines for diagnosis of CS (Nieman 2008). Previous medical records will be collected and used to support the diagnosis. The diagnostic criteria for appropriateness of inclusion of each subject into the study will be reviewed by the Medical Monitor. Diagnosis of the disease will be based on the association of clinical features of endogenous CS (see Appendix G in clinical protocol), review of past medication history, excluding exogenous sources of glucocorticoids, and abnormal values from two of the three following tests:
    • Elevated 24-hour UFC levels ≥1.5X ULN of assay based on a minimum of 4 measurements from adequately collected urine. Urine may be collected on sequential days.
    • Abnormal DST: Elevated 8 AM serum cortisol ≥1.8 ug/dL (50 nmol/L) after 1 mg dexamethasone orally at 11 PM the evening prior (if not conducted already in the diagnostic workup of the subject within the previous 6 months; previous test results and details of conduct will need to be available; normal serum cortisol ≤ 1.4 ug/dL)
    • Elevated late night salivary cortisol concentrations (at least 2 measurements) >ULN at screening
    • [NOTE: For subjects with estimated glomerular filtration rate (eGFR as determined by MDRD equation >40 and <60 mL/min) a late night salivary cortisol test (≥2 measurements) MUST be conducted in addition to measuring UFC levels to demonstrate evidence of CS.]
  • Previously irradiated subjects will be allowed as long as the radiation treatment occurred ≥2 years ago and they do have stable UFC levels based on 24-hour urine collections for at least 6 months. The total number of previously irradiated subjects will not exceed 10.
    • In the vast majority of subjects treated with radiation, efficacy is observed in <2 years.
  • Confirmed diagnosis of persistent or recurrent endogenous hypercortisolemia as defined by UFC concentrations on repeated determinations (described in Inclusion #2) caused by either ACTH-dependent or ACTH-independent etiologies.
  • Subjects on treatment for CS for whom treatment has been inadequate or not well tolerated must agree to the following minimum washout periods as determined by the nature of their treatment before baseline assessments are performed for participation in this study:
    • Inhibitors of steroidogenesis: 2weeks; subjects on ketoconazole will be considered inadequately treated if they had failed to normalize UFC with a dose lower than or equal to 600 mg/day (also see Exclusion 7 below).
    • Dopamine agonists: bromocriptine (2 week), cabergoline (8 weeks)
    • Octreotide acetate LAR and lanreotide Autogel®: 12 weeks
    • Lanreotide SR/long-acting pasireotide: 8 weeks
    • Octreotide acetate (immediate release formulation) or short-acting pasireotide: 1 week
    • Mifepristone (RU 486): 4 weeks
  • Subjects on megasterol acetate (medroxyprogesterone acetate) must agree to a wash out of ≥6 weeks prior to receiving the first dose of the study medication.
  • Female subjects should be either post-menopausal, surgically sterile, or women of child-bearing potential (WOCP) with a negative serum beta human chorionic gonadotropin (ßhCG) pregnancy test prior to entering the study and who agree to use an acceptable method of contraception, for the duration of the study. Condoms will be considered an acceptable form of contraceptive.
  • 12-lead ECGs show no acute ischemia or clinically significant abnormality needing medical intervention
  • Ability to comprehend and comply with procedures
  • Agree to commit to participate in the current protocol
  • Subjects provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)

Exclusion Criteria:

Subjects will be excluded from the study if any of the following criteria are met:

  • De novo Cushing´s disease AND a candidate for pituitary surgery
    • If surgery is to be delayed for >5 months, subjects may be allowed to participate in the trial while awaiting surgery, but must agree to complete this study prior to surgery.
  • Subjects treated with radiation within the previous 2 years.
    • In the vast majority of subjects treated with radiation, efficacy is observed in <2 years.
  • Characteristics of pseudo-CS (see Appendix H in clinical protocol)
  • Subjects with adrenal carcinoma
  • Body Mass Index (BMI) exceeding 50 kg/m2
  • Body habitus preventing repeated venipuncture as required by protocol
  • Subject is currently in another study or has received any investigational treatment (drug, biological agent or device) within 30 days or 5 half lives of screening, whichever is longer
  • History of significant abnormalities in liver function tests on ketoconazole; history of therapeutic response failure to ketoconazole as defined by lack of normalization of UFC at a dose greater than 800 mg/day; lack of therapeutic response failure at maximum dose of mitotane
  • Male and female subjects with QTc interval of >470 msec
  • History of Torsades des Pointes or ventricular tachycardia or ventricular fibrillation
  • Subjects with a non-endogenous source of hypercortisolemia such as exogenous source of glucocorticoids or therapeutic use of ACTH
  • History of malignancy, other than thyroid, early stage prostate, squamous cell and basal cell carcinoma, within 3 years prior to the initial dose of the study medication. Subjects with history of carcinoma must have a life expectancy of >1 year and must be on stable doses of their specific therapies. Subjects with early stage prostate cancer undergoing no treatment due to low grade potential may be enrolled.
  • Diagnosis of HIV
  • History of persistent uncontrolled hypertension (>210/110 mmHg) despite medical intervention
  • Subjects with hypercholesterolemia who are on current atorvastatin or simvistatin and not willing or unable to change to alternative therapies as noted (pravastatin, fluvastatin, and rosuvastatin) with 2 weeks of study screening
  • Subjects with T2DM or with a history of hyperglycemic episodes requiring repeated, frequent hospitalizations
  • Subjects with decreased renal function as defined by eGFR ≤40 mL/min, using Modified Diet in Renal Disease (MDRD) equation for estimating renal function (eGFR).
  • Any other clinically significant medical condition, as determined by the Investigator that precludes enrollment and participation in the study through completion (for example, New York Heart Association (NYHA) class III or IV congestive heart failure).
  • Known hepatic disease, other than mild to moderate hepatic steatosis consistent with fatty infiltration (non-alcoholic steatohepatitis [NASH]), with ongoing sustained biochemical activity (subjects with CS would be at risk for NASH)
  • History of recurrent gall stone attacks or pancreatitis
  • Positive for hepatitis B surface antigen (HbsAg) or positive hepatitis C test
  • Liver function tests (LFT) must not be above the following cut-offs at screening: ALT and/or AST >3.0X ULN, alkaline phosphatase (AP) >1.5X ULN and total bilirubin >ULN. If all LFTs are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are presumed to have Gilbert’s syndrome and may be enrolled if all other LFTs are WNL.
  • Presence of any other clinically significant medical condition, as determined by the Investigator that would preclude the subject from being able to follow instructions or to perform the necessary procedures (for example, psychiatric instability or severe disability)
  • Compression of the optic chiasm
  • Abnormal free T4. Subjects with TSH
  • Excessive alcohol intake (>20 g per day for females (1.5 standard alcohol drinks) or >30 g per day for males (2.0 standard alcohol drinks) (a standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine or 1.5 oz of spirits) or drug abuse. (1.0 fluid oz (US) = 29.57 ml)
  • The subject is currently taking any H2 receptor antagonists or proton-pump inhibitors (which inhibit absorption of COR-003). Only over-the- counter liquid and tablet antacids are allowed which should be used in moderation and taken a minimum of 2 hours after dosing of COR-003.
  • The subject is receiving the following concomitant therapies:
    • Weight loss medications (prescription or over the counter)
    • Coadministration of COR-003 and drugs primarily metabolized by the cytochrome P450 3A4 enzyme system may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic and/or adverse effects. Therefore, appropriate dosage adjustments may be necessary.
    • Medications with metabolism largely mediated by CYP3A4 and a narrow therapeutic margin include: cyclosporine, midazolam, triazolam, alprazolam, digoxin, coumarin-derivatives, phenytoin, rifampin, erythromycin, clarithromycin, loratadine, astemizole, terfenadine, nicotinic acids, resins, orlistat, sibutramine, HIV protease inhibitors, thiazolidinodiones, aliskiren, and spironolactone.
    • A complete list of medications metabolized by or with an effect on cytochrome P450 3A4 is provided in Appendix K. Also see Section 10.2.
    • Coadministration of strong inducers or inhibitors of CYP3A4 enzyme system that may interfere with COR-003 and cannot be discontinued prior to the start of the study (see Appendix K for the list)
    • Statins other than pravastatin, fluvastatin and rosuvastatin
    • Following herbal medicines should be avoided: St John’s Wort, yohimbe and red rice yeast
    • Potent topical steroids, containing urea or salicylic acid, which are applied over 20% of the body
    • Inhaled steroid medications that exceed minimal to moderate use
    • Carbamazipine, fenofibrate, carbenoxolone
    • Excessive ingestion of genuine licorice
  • Pregnant or lactating women
  • Any other condition which would increase the risk of participation in the trial in the opinion of the Investigator

Contact

Adrine Gdakian
UCLA School of Medicine
700 Tiverton Avenue, Factor Building Rm 9-240
Los Angeles, CA 90095
Phone: 310-825-5874
Fax: 310-206-5553

Jessica Rios-Santiago
Coastal Metabolic Research Center University Medical Center, Dept. of Endocrinology
3454 Loma Vista Rd.
Ventura, CA 93003
Phone: 805-658-8460
Fax: 805-658-8462

Betsy Parrott, RN, CCRC
Rhode Island Hospital, Hallett Center for Diabetes and Endocrinology
900 Warren Avenue, Suite 300
East Providence, RI 02914
Phone: 401-444-2091
Fax: 401-444-4921

Becky Wood, CCRP
Swedish Neuroscience Research
500 17th Ave
Professional Bldg 303
Seattle, WA 98122
Phone: 206-320-7115

Clinical Trial for Cortendo

Cortendo Clinical Trial

 

About the Study

OBJECTIVE:

The purpose of this study is to test the effects of different doses of COR-003 on people with endogenous Cushing’s syndrome, primarily by measuring the cortisol levels in urine and secondarily by measuring other health parameters such as blood pressure, weight, liver function, etc. This study is also being conducted to find out if COR-003 is safe to use. This study is open-label, which means both the health providers and the participants in the study are aware of the drug or treatment being given.

STUDY DESIGN:

  • The study will begin with a screening period to make sure subjects are eligible to participate in the study.
  • After the screening period, subjects who are eligible for participation will each be given several different doses of COR-003, to be taken by mouth in tablet form.
  • After an individualized dose has been selected, participants will take COR-003 for 6 months.
  • Finally, participants will continue in the study for an additional 6 months at doses to be determined by the study doctor.
  • Throughout the study, participants will meet regularly with a study doctor and will take part in a variety of medical tests to make sure they are doing well and to see if COR-003 is working.
  • Participants in the study should be sure they have the time to participate. Participants will generally be followed for over a year.

See if you may be eligible for this clinical study. By providing your contact information, you will receive more information about the study and your eligibility.

About Cortendo

Cortendo is the sponsor of this study. This means Cortendo planned and organized this study. Cortendo will also collect and analyze the data from the study.

Cortendo is a global pharmaceutical company primarily focused on researching and providing treatments for rare diseases in endocrinology, such as Cushing’s syndrome. The company was founded in Sweden and its worldwide headquarters is located just outside of Philadelphia.

Fill out this form for more information: https://www.cushingssyndromestudy.com/registration.aspx

Research Study: An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome

Objectives:         

The purpose of this study is to test the effects of different doses of COR-003 on people with Cushing’s syndrome (CS) primarily by measuring the cortisol levels in urine and secondarily by measuring other health parameters such as blood pressure, weight, and liver function. This study is also being conducted to see if there is any harm caused when using COR-003.

This study is an open label study. That means both the health providers and the participants in the study are aware of the drug or treatment being given.

Eligibility:

Adult Subjects (18 years or older) with elevated levels of cortisol due to endogenous CS.

Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if subjects are not candidates for surgery. CS will be defined according to the criteria in the guidelines for diagnosis of CS (Nieman 2008).

Women who are pregnant or lactating are not eligible for this study.

Individuals with other health conditions or diagnoses may not be eligible for this study.

These and other eligibility criteria are best reviewed with a doctor who is participating in the study. You can also get more detailed eligibility information about the study by clicking here to visit http://www.clinicaltrials.gov.

Study Design:

  • The study will begin with a screening period to make sure subjects are eligible to participate in the study.
  • After the screening period, subjects who are eligible for participation will each be given several different doses of COR-003, to be taken orally in tablet form.
  • After an individualized dose has been selected, participants will take COR-003 for six months.
  • Finally, participants will continue in the study for an additional six months at doses to be determined by the study doctor.

 

Throughout the study, participants will meet regularly with a study doctor and will take part in a variety of medical tests to make sure they are doing well and to see if COR-003 is working.

Participants in the study should be sure they have the time to participate. Participants will generally be followed for over a year:

Study Locations

The study is currently taking place in several places around the world (United States, Belgium, France, Israel, Netherlands, Spain, and Sweden).
Additional information on the study can be found at clinicaltrials.gov through this link.

Study sponsor: Cortendo AB

For more information, please contact:

Jim Ellis at Cortendo AB tel: +1 (610) 254-9245 or jellis@cortendo.com

 

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