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
- Conditions
- AcromegalyTherapeutic area: Diseases [C] - Hormonal diseases [C19]MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
- Registration Number
- EUCTR2018-002230-20-GB
- Lead Sponsor
- Crinetics Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 45
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
1.Treatment naïve acromegaly subjects
2.Prior treatment with CRN00808
3.Pituitary surgery within 6 months prior to Screening or subjects in
Group 3, 4, or 5 who have undergone pituitary radiation therapy at any
time prior to the study entry. A history of radiation therapy is not a
restriction for subjects in Group 1 or 2. If a subject in Group 3, 4, or 5
has undergone pituitary radiation therapy =4 years prior to Screening
and has had a documented IGF-1 =1.3×ULN within 2 years prior to Screening OR if a subject has undergone pituitary radiation therapy between 3 and 4 years prior to Screening and has had a documented IGF-1 =1.3×ULN within 1 year
prior to Screening, the subject may be included in the study;
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.Subjects with hepatitis B, Human Immunodeficiency Virus (HIV), or
hepatitis C infection. Subjects with previous hepatitis C infection that is
now cured may be eligible.
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 mediations 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);
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: 1.To evaluate the efficacy of CRN00808 in acromegaly subjects treated<br> with somatostatin analogue based treatment regimens;<br> 2.To evaluate the safety and tolerability of CRN00808 in acromegaly<br> subjects;<br> 3.To evaluate the pharmacokinetics (PK) of CRN00808 in acromegaly<br> subjects.<br> ;Primary end point(s): Change from baseline(mean of Screening values) in IGF-1 level at W13;Timepoint(s) of evaluation of this end point: Week 13;Secondary Objective: NA
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1.Proportion of subjects with the mean of their last two consecutive IGF-<br> 1 measurements =ULN;<br> 2.Proportion of subjects with the mean of their last two consecutive IGF-<br> 1 measurements =1.5×ULN<br> ;Timepoint(s) of evaluation of this end point: Week 13