An exploratory Phase 2 study to evaluate the Safety and Efficacy of CRN00808 for the treatment of acromegaly

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

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
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

Exclusion Criteria

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
Main Objective: 1.To evaluate the efficacy of CRN00808 in acromegaly subjects treated with somatostatin analogue based treatment regimens;<br>2.To evaluate the safety and tolerability of CRN00808 in acromegaly subjects;<br>3.To evaluate the pharmacokinetics (PK) of CRN00808 in acromegaly subjects.<br>;Secondary Objective: NA;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: 13 weeks

Secondary Outcome Measures

Name	Time	Method
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

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