Mittwoch, 1. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
ACSPIRE

SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

Rekrutierend

NCT-Nummer:
NCT05436639

Studienbeginn:
Juli 2023

Letztes Update:
19.04.2024

Wirkstoff:
SPI-62 dose1, SPI-62 dose 2, SPI-62 dose 3, SPI-62 dose 4, Placebo

Indikation (Clinical Trials):
Adrenal Gland Neoplasms, Cushing Syndrome, Adrenocortical Hyperfunction, Syndrome

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Sparrow Pharmaceuticals

Collaborator:
-

Studienleiter

Frank Czerwiec, MD
Study Chair
Sparrow Pharmaceuticals

Kontakt

Studienlocations
(3 von 25)

Kaiser Permanente LAMC
90027 Los Angeles
United StatesZurückgezogen» Google-Maps
IU Simon Cancer Center - Indiana University
46202 Indianapolis
United StatesZurückgezogen» Google-Maps
University of Michigan
48109 Ann Arbor
United StatesZurückgezogen» Google-Maps
Washington University School of Medicine - Center for Advanced Medicine (CAM) - Diabetes Center
63110 Saint Louis
United StatesZurückgezogen» Google-Maps
Rhode Island Hospital
02903 Providence
United StatesZurückgezogen» Google-Maps
Eastern Virginia Medical School - Strelitz Diabetes Center
23510 Norfolk
United StatesZurückgezogen» Google-Maps
CHU Hôpitaux de Rouen
76230 Bois-Guillaume
FranceZurückgezogen» Google-Maps
Hôpital de la Conception
13385 Marseille
FranceZurückgezogen» Google-Maps
Spitalul Clinic Judeţean de Urgenţe "Sf. Spiridon"
700115 Iași
RomaniaZurückgezogen» Google-Maps
Universitatea de Medicina si Farmacie Targu Mures - Spitalul Clinic Judetean de Urgenta Targu Mures
540136 Târgu-Mureş
RomaniaZurückgezogen» Google-Maps
University Hospital of Wales
CF14 4XW Cardiff
United KingdomZurückgezogen» Google-Maps
Leeds Teaching Hospitals NHS Trust
LS9 7TF Leeds
United KingdomZurückgezogen» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomZurückgezogen» Google-Maps
Manchester University NHS Foundation Trust - Wythenshawe Hospital
M23 9QZ Manchester
United KingdomZurückgezogen» Google-Maps
Salford Royal NHS Foundation Trust
M5 5AP Salford
United KingdomZurückgezogen» Google-Maps
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
SO16 6YD Southampton
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multicenter, Phase 2 study to estimate SPI-62's effect on clinical features of

hypercortisolism related to a benign adrenal tumor, including diabetes/impaired glucose

tolerance, hyperlipidemia, hypertension, and osteopenia. Each subject who provides consent

and meets all inclusion and exclusion criteria will participate in a screening period and an

open-ended treatment period. Visits occur at screening/baseline, months 1, 3, 6, 9, and 12,

and then quarter-annually.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Diagnosis and main criteria for inclusion and exclusion:

The following are the main inclusion criteria:

- Adults able to provide informed consent.

- Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous

texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be

non malignant.

- Diagnosis of diabetes mellitus, pre-diabetes or impaired glucose tolerance, either

untreated or on stable standard of care treatment, based on at least one of:

- HbA1c ≥ 5.7% but not > 9.5%

- 2-hour glucose level ≥ 7.8 mmol (140 mg/dL) on a 75 g OGTT

- At least one additional documented cortisol-related morbidities, either untreated or

on stable standard of care treatment:

- hypercholesterolemia with total cholesterol > 3.9 mM (150 mg/dL);

- hypertriglyceridemia with triglycerides > 2.3 mM (200 mg/dL);

- osteopenia with bone densitometry Z-score < -2.0 or T-score < -1.0;

- history or evidence of minimally traumatic or osteoporotic fracture; or

- hypertension with resting supine blood pressure > 130 but < 180 mmHg systolic or

> 85 but < 120 mmHg diastolic.

- Poorly suppressible hypercortisolemia:

- Morning serum cortisol > 50 nM (1.8 mcg/dL) after a 1 mg ONDST.

- Subjects with dexamethasone < 3.3 nmol/L (130 ng/dL) will undergo a high-dose (8

mg) ONDST.

- Subjects who take estrogen-containing medicines will be evaluated based on free

cortisol > 2.2 nM (80 ng/dL).

- For subjects with morning serum cortisol > 138 nM (5.0 mcg/dL) after ONDST, the

Investigator will assess for adrenal Cushing's syndrome.

Exclusion Criteria:

- Diagnosis of ACTH-dependent Cushing's syndrome, pheochromocytoma, aldosteronoma,

adrenocortical carcinoma, or congenital adrenal hyperplasia, or other malignancy

associated hypercortisolism including history of adrenal carcinoma.

- History of adrenalectomy or planned adrenalectomy within 4 months after randomization.

- Exogenous hypercortisolism.

- Uncontrolled, clinically significant hypo- or hyperthyroidism.

- History of idiopathic thrombocytopenia.

- Moderately impaired renal function (estimated glomerular filtration rate < 60

mL/min/1.73m2).

- History of cancer (other than non-melanoma skin, thyroid, or early-stage prostate

cancer) within 3 years.

- Any major surgery, or significant post-operative sequelae, within 1 month prior to

informed consent or planned during the trial.

- Pregnant or lactating.

- Positive test for severe acute respiratory syndrome coronavirus 2 infection within 4

weeks, or hospitalization for Coronavirus disease 2019 within 6 months, prior to

randomization.

- Any other current or prior medical condition expected to interfere with the conduct of

the trial or the evaluation of its results.

- Participation in any clinical trial within 3 months prior to the first dose of study

drug, or longer depending on half-life of the investigational therapy.

Studien-Rationale

Primary outcome:

1. Change in HbA1c at Week 6 (Time Frame - Baseline to week 6):
HbA1c change from baseline

2. Change in HbA1c at week 12 (Time Frame - Baseline to week 12):
HbA1c change from baseline

Studien-Arme

  • Experimental: SPI-62 dose 1
    0.2mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
  • Experimental: SPI-62 dose 2
    0.6mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
  • Experimental: SPI-62 dose 3
    2mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
  • Experimental: SPI-62 dose 4
    6mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
  • Placebo Comparator: Placebo
    Placebo by mouth each morning for up to 12 weeks.

Geprüfte Regime

  • SPI-62 dose1:
    SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 1 of drug (0.2mg).
  • SPI-62 dose 2:
    SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (0.6mg).
  • SPI-62 dose 3:
    SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (2mg).
  • SPI-62 dose 4:
    SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (6mg).
  • Placebo:
    Inactive tablets identical to SPI-62 tablets.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.