A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04837040 |
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Recruitment Status :
Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : November 14, 2022
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Sponsor:
Crinetics Pharmaceuticals Inc.
Information provided by (Responsible Party):
Crinetics Pharmaceuticals Inc.
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Brief Summary:
A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acromegaly | Drug: Paltusotine Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 58 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1) |
| Actual Study Start Date : | May 12, 2021 |
| Estimated Primary Completion Date : | July 2023 |
| Estimated Study Completion Date : | June 2025 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Paltusotine |
Drug: Paltusotine
Paltusotine, tablets, once daily by mouth
Other Name: CRN00808 |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo, tablets, once daily by mouth |
Primary Outcome Measures :
- Proportion of subjects who maintain biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR) [ Time Frame: 36 Weeks ]
Secondary Outcome Measures :
- Change from baseline in IGF-1, in units of ULN, to EOR [ Time Frame: 36 Weeks ]
- Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline [ Time Frame: 34 Weeks ]
- Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR [ Time Frame: 36 Weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects ≥18 years of age
- Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy
- Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
- Willing to provide signed informed consent
Exclusion Criteria:
- Treatment naïve or treatment-withdrawn acromegaly subjects
- Prior treatment with paltusotine
- Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy
- History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
- Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
- Known history of HIV, hepatitis B, or active hepatitis C
- History of alcohol or substance abuse in the past 12 months
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
- Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
- Subjects with symptomatic cholelithiasis
- Subjects with clinically significant abnormal findings during the Screening Period, or 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
- Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837040
Locations
| United States, Arizona | |
| Crinetics Study Site | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Crinetics Study Site | |
| Los Angeles, California, United States, 90048 | |
| Crinetics Study Site | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Crinetics Study Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Crinetics Study Site | |
| Miami, Florida, United States, 33136 | |
| United States, Maryland | |
| Crinetics Study Site | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Crinetics Study Site | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Pennsylvania | |
| Crinetics Study Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Crinetics Study Site | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Tennessee | |
| Crinetics Study Site | |
| Nashville, Tennessee, United States, 37203 | |
| Argentina | |
| Crinetics Study Site | |
| Caba, Buenos Aires, Argentina, C1012AAR | |
| Crinetics Study Site | |
| Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1405BCH | |
| Crinetics Study Site | |
| Córdoba, Argentina, X5000 | |
| Belgium | |
| Crinetics Study Site | |
| Gent, Belgium, 9000 | |
| Brazil | |
| Crinetics Study Site | |
| Fortaleza, Ceará, Brazil, 60430-275 | |
| Crinetics Study Site | |
| Curitiba, Paraná, Brazil, 80030-110 | |
| Crinetics Study Site | |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90410-000 | |
| Crinetics Study Site | |
| Ribeirão Preto, São Paulo, Brazil, 14051-140 | |
| Crinetics Study Site | |
| Rio De Janeiro, Brazil, 21941-913 | |
| Crinetics Study Site | |
| São Paulo, Brazil, 01228000 | |
| Crinetics Study Site | |
| São Paulo, Brazil, 05453-000 | |
| Bulgaria | |
| Crinetics Study Site | |
| Sofia, Bulgaria, 1431 | |
| France | |
| Crinetics Study Site | |
| Bron, France, 69677 | |
| Crinetics Study Site | |
| Pessac, France, 33604 | |
| Hungary | |
| Crinetics Study Site | |
| Budapest, Hungary, 1083 | |
| Crinetics Study Site | |
| Pécs, Hungary, 7624 | |
| Israel | |
| Crinetics Study Site | |
| Be'er Sheva, Israel, 8410101 | |
| Crinetics Study Site | |
| Petach Tikva, Israel, 4941480 | |
| Crinetics Study Site | |
| Tel Aviv, Israel, 6423906 | |
| Italy | |
| Crinetics Study Site | |
| Pisa, Italy, 56124 | |
| Crinetics Study Site | |
| Roma, Italy, 00168 | |
| Peru | |
| Crinetics Study Site | |
| San Isidro, Lima, Peru, 15023 | |
| Poland | |
| Crinetics Study Site | |
| Bydgoszcz, Poland, 85-605 | |
| Crinetics Study Site | |
| Poznań, Poland, 60-355 | |
| Crinetics Study Site | |
| Wrocław, Poland, 50-367 | |
| Russian Federation | |
| Crinetics Study Site | |
| Kemerovo, Kemerovo Oblast, Russian Federation, 650066 | |
| Crinetics Study Site | |
| Novosibirsk, Novosibirsk Oblast, Russian Federation, 630005 | |
| Crinetics Study Site | |
| Novosibirsk, Novosibirsk Oblast, Russian Federation, 630087 | |
| Crinetics Study Site | |
| Kazan, Republic Of Tatarstan, Russian Federation, 420097 | |
| Crinetics Study Site | |
| Samara, Samara Oblast, Russian Federation, 443041 | |
| Crinetics Study Site | |
| Moscow, Russian Federation, 117186 | |
| Crinetics Study Site | |
| Moscow, Russian Federation, 125008 | |
| Serbia | |
| Crinetics Study Site | |
| Belgrade, Serbia, 11000 | |
| United Kingdom | |
| Crinetics Study Site | |
| Sheffield, South Yorkshire, United Kingdom, S102JF | |
| Crinetics Study Site | |
| Coventry, West Midlands, United Kingdom, CV2 2DX | |
| Crinetics Study Site | |
| London, United Kingdom, W12 0HS | |
Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.
Additional Information:
| Responsible Party: | Crinetics Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT04837040 |
| Other Study ID Numbers: |
CRN00808-09 2020-005431-70 ( EudraCT Number ) |
| First Posted: | April 8, 2021 Key Record Dates |
| Last Update Posted: | November 14, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Crinetics Pharmaceuticals Inc.:
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Acromegaly PATHFNDR Paltusotine CRN00808 |
Additional relevant MeSH terms:
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Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |