Clinical trial NCT03789656: An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)
Official title: An Open Label Exploratory Study to Evaluate the Safety, Pharmacokinetics and Efficacy of CRN00808 in Patients With Acromegaly Treated With Somatostatin Analogue Based Treatment Regimens (ACROBAT Edge)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acromegaly
Keywords: Acromegaly
ACROBAT
EDGE
Paltusotine
Lead sponsor: Crinetics Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects 18 to 75 years of age
2. Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
4. Willing to provide signed informed consent

Exclusion Criteria:

1. Treatment naïve acromegaly subjects
2. Prior treatment with paltusotine
3. Pituitary surgery within 6 months prior to Screening. Subjects receiving radiation therapy may be eligible with some restrictions.
4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
6. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
7. History of alcohol or substance abuse in the past 12 months
8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
10. Subjects with symptomatic cholelithiasis
11. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
12. Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg
13. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Primary outcomes:
measure: Change From Baseline (Median of Screening Values) in Insulin-like Growth Factor-1 (IGF-1) Level
timeFrame: 13 Weeks
Secondary outcomes:
measure: Proportion of Subjects With Their Last IGF-1 Measurement ≤ Upper Limit of Normal (ULN)
timeFrame: 13 Weeks
measure: Proportion of Subjects With Their Last IGF-1 Measurements ≤1.5×ULN
timeFrame: 13 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Gonda Diabetes Center
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Portland
country: United States
facility: OHSU Northwest Pituitary Center
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Endocrinology Associates
state: Pennsylvania
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras
city: Rio De Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho (HUCFF/UFRJ) Centro de Pesquisa em Neuroendocrinologia
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica
city: Munich
country: Germany
facility: LMU Clinic of University of Munich
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos"
city: Athens
country: Greece
facility: General Hospital of Athens "Gennimatas"
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
city: Thessaloníki
country: Greece
facility: General Hospital of Athens "Ippokratio"
city: Budapest
country: Hungary
facility: Military Health Center, Division of Endocrinology
city: Budapest
country: Hungary
facility: Semmelweis University Faculty of Medicine
city: Pécs
country: Hungary
facility: University of Pécs Medical School
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Takapuna
country: New Zealand
facility: Waitemata District Health Board, North Shore Hospital
city: Wellington
country: New Zealand
facility: Endocrine, Diabetes and Research Centre, Wellington Hospital
city: Krakow
country: Poland
facility: Clinic of Endocrinology Independent Public Health Care Centre University Hospital in Kracow
city: Bucharest
country: Romania
facility: National Institute of Endocrinology "C. I. Parhon"
city: Belgrade
country: Serbia
facility: Clinical Centre Serbia, Clinic for Endocrinology, Diabetes and Metabolic Diseases
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References: