Clinical trial • Phase III • Oncology

PALTUSOTINE for Carcinoid syndrome | Well-differentiated neuroendocrine tumor

Phase III trial of PALTUSOTINE for Carcinoid syndrome | Well-differentiated neuroendocrine tumor.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Carcinoid syndrome | Well-differentiated neuroendocrine tumor
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-04-2025
First CTIS Authorization Date
28-07-2025

Trial design

Randomised, placebo (matching placebo to paltusotine 40 mg tablets) versus paltusotine 40 mg tablets (oral daily paltusotine regimen; product labelled as 40 mg tablets; product metadata lists max daily dose 80 mg).-controlled Phase III trial across 45 sites in France, Belgium, Germany and others.

Randomised
Yes
Comparator
Placebo (matching placebo to Paltusotine 40 mg tablets) versus Paltusotine 40 mg tablets (oral daily paltusotine regimen; product labelled as 40 mg tablets; product metadata lists max daily dose 80 mg).
Target Sample Size
83
Trial Duration For Participant
120

Eligibility

Recruits 83 isVulnerablePopulationSelected: true. Consent requirement (verbatim): "1. Willing and able to provide written informed consent prior to any study-related procedures." Participants are adults ("Male or female ≥18 years of age, at the time of Screening."). No assent/parental consent procedures for minors are described in the available CTIS records..

Vulnerable Population
isVulnerablePopulationSelected: true. Consent requirement (verbatim): "1. Willing and able to provide written informed consent prior to any study-related procedures." Participants are adults ("Male or female ≥18 years of age, at the time of Screening."). No assent/parental consent procedures for minors are described in the available CTIS records.

Inclusion criteria

  • {"criterion_text":"- 1. Willing and able to provide written informed consent prior to any study-related procedures."}
  • {"criterion_text":"- 10. Male participants must agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile [ie, vasectomy with a confirmed absence of sperm in ejaculate] or agree to remain abstinent on a long-term and persistent basis). Male participants should also agree to not donate sperm for the duration of the study and until at least 2 weeks after the last dose of study drug."}
  • {"criterion_text":"- 2. Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the Carcinoid Syndrome Symptom Diary for the 2-week period prior to the S2 Visit and prior to the Day 1 Visit."}
  • {"criterion_text":"- 3. Male or female ≥18 years of age, at the time of Screening."}
  • {"criterion_text":"- 4. Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:  For participants who are naïve/not currently treated with SRLs, they must exhibit an average of >1 flushing episode/day over a period of 14 days and have a screening plasma 5-HIAA or serotonin result ≥2×ULN.  For participants who will wash out from SRL treatment, they must exhibit an increase in daily average flushing episodes and an average of >1 flushing episode/day over a period of 14 days during the Washout Period."}
  • {"criterion_text":"- 5. Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated NET(s). Tumors must be Grade 1 or Grade 2 (Ki-67 index ≤20%, or a mitotic count of ≤20 mitoses per 10 high-power fields if the Ki-67 index is not available) per the World Health Organization neuroendocrine neoplasm classification. Participants with Grade 3 tumors are not eligible."}
  • {"criterion_text":"- 6. No significant disease progression as assessed by the Investigator within the last 6 months before randomization into the RCP. Note: A CT or MRI scan will be performed during the Screening Period and should be compared with previous pretrial imaging to assess disease stability for established participants on SRL maintenance therapy, while clinical symptoms and/or biomarker assessments should be used to assess disease stability for newly diagnosed participants naïve to SRLs."}
  • {"criterion_text":"- 7. Historical documentation of positive somatostatin receptor tumor status by PET or somatostatin receptor scintigraphy. Note: If participant does not have historical documentation, this can be done during the Screening Period."}
  • {"criterion_text":"- 8. Participants who are currently treated with octreotide/lanreotide and who agree to wash out of treatment must have historical instance of an elevated 5-HIAA or serotonin level, using either a urine or blood sample."}
  • {"criterion_text":"- 9. Female participants who engage in heterosexual intercourse must:  Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), OR  Be postmenopausal with at least 1 year of amenorrhea. In participants with less than 1 year of amenorrhea, confirmation is required with 2 FSH measurements. A documented, historical test result measured prior to Screening may be used as 1 of the 2 measurements. The FSH value should be ≥30 IU/L to confirm menopausal status, OR  Agree to use a highly effective method of contraception from the beginning of the Screening Period until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Periodic abstinence (ie, calendar, ovulation, symptothermal, and postovulation methods) and withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together."}

Exclusion criteria

  • {"criterion_text":"- 1. Diarrhea attributed to any condition(s) other than carcinoid syndrome."}
  • {"criterion_text":"- 10. Unable to administer SA octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists."}
  • {"criterion_text":"- 11. Known allergy or hypersensitivity to any of the test materials or related compounds."}
  • {"criterion_text":"- 12. Any clinically significant and active infection such as those requiring systemic treatment within 14 days before randomization."}
  • {"criterion_text":"- 13. Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate <30 mL/min/1.73 m2, cirrhosis, baseline AST and/or ALT >2×ULN, and/or TB >1.5×ULN. (Participants with previously diagnosed Gilbert’s syndrome not accompanied by other hepatobiliary disorders and associated with TB <3.5 mg/dL [<51.3 µmol/L] will be permitted.)"}
  • {"criterion_text":"- 14. Current alcohol or drug abuse, or within the last year, is not permitted."}
  • {"criterion_text":"- 2. Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension."}
  • {"criterion_text":"- 3. Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator."}
  • {"criterion_text":"- 4. Treatment with specific NET therapy <4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, PRRT, and/or tumor debulking <12 weeks before Screening."}
  • {"criterion_text":"- 5. Major surgery within 8 weeks before Screening."}
  • {"criterion_text":"- 6. History of another primary malignancy <3 years prior to the date of randomization in the RCP unless at least 1 of the following criteria are met:  Adequately treated basal or squamous cell carcinoma of the skin.  Cancer of the breast or cervix in situ.  Previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease.  Concurrent malignancy determined to be clinically stable and not requiring treatment."}
  • {"criterion_text":"- 7. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry."}
  • {"criterion_text":"- 8. Poorly controlled diabetes mellitus defined as having a HbA1c ≥8.5% (ie, ≥69.5 mmol/mol) or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathy)."}
  • {"criterion_text":"- 9. History of unstable angina or acute myocardial infarction within the 12 weeks preceding the Screening Period or other clinically significant cardiac disease (including clinically significant carcinoid heart disease) at the time of Screening as judged by the Investigator."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.","definition_or_measurement_approach":"Change from baseline to Week 12 in flushing episodes per day, averaged over the 14 days prior to Week 12 (i.e. mean daily flushing episodes over the 14-day window before Week 12 compared between treatment groups)."}

Secondary endpoints

  • {"endpoint_text":"- Key Secondary: Treatment group difference of change from baseline to Week 12 in BMs/day averaged over the 14 days.","definition_or_measurement_approach":"Change from baseline to Week 12 in bowel movements per day, averaged over the 14-day assessment window (mean daily BMs over 14 days prior to Week 12 compared between groups)."}

Recruitment

Planned Sample Size
83
Recruitment Window Months
48
Consent Approach
Written informed consent is required from each participant: "Willing and able to provide written informed consent prior to any study-related procedures." Participants are adults (≥18). Subject information and informed consent forms (SIS and ICF) are available in multiple language versions (examples: English, French, Spanish, Italian, Polish, Romanian, Dutch/German variants as indicated by multiple country-specific ICF documents). Additional ICF materials for pregnant participants/partners are provided.

Methods

  • Country-specific recruitment materials provided (Patient Letter, Patient Brochure) — examples present: K2_EN_Recruitment material_Patient Brochure, K2_FR-FR_Recruitment material_Patient Brochure, K2_PL_Recruitment material_PatientBrochure etc.
  • Patient letters (documented per-country: e.g. K2_FR-FR_Recruitment material_Patient Letter, K2_BE_Recruitment arrangements) intended to invite/ inform potential participants.
  • Washout / Rescue Medicine information materials provided for participants who will wash out from SRL therapy (documents titled WashoutRescueMedInfo per country).
  • Study brochures / scout materials for patient engagement (e.g. L2_FR-FR_Other subject information material_ScoutBrochure; L2_ES_ES_Other subject information material_Scout Study Brochure).

Geography

Total Number Of Sites
45
Total Number Of Participants
97

France

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
70
Number Of Sites
10
Number Of Participants
16

Sites

Site Name
Hospices Civils De Lyon
Department Name
Oncologie médicale
Principal Investigator Name
Alice Durand
Principal Investigator Email
alice.durand@chu-lyon.fr
Contact Person Name
Alice Durand
Contact Person Email
alice.durand@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hepatologie, gastro-enterologie et oncologie
Principal Investigator Name
Yann Touchefeu
Principal Investigator Email
yann.touchefeu@chu-nantes.fr
Contact Person Name
Yann Touchefeu
Contact Person Email
yann.touchefeu@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Oncologie médicale
Principal Investigator Name
Rosine Guimbaud
Principal Investigator Email
guimbaud.r@chu-toulouse.fr
Contact Person Name
Rosine Guimbaud
Contact Person Email
guimbaud.r@chu-toulouse.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hepatologie, gastro-enterologie et oncologie digestive
Principal Investigator Name
Thierry Lecomte
Principal Investigator Email
thierry.lecomte@med.univ-tours.fr
Contact Person Name
Thierry Lecomte
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastro-enterologie et hepatologie
Principal Investigator Name
Louis De Mestier
Principal Investigator Email
louis.demestier@aphp.fr
Contact Person Name
Louis De Mestier
Contact Person Email
louis.demestier@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncologie digestive
Principal Investigator Name
Laetitia Dahan
Principal Investigator Email
laetitia.dahan@ap-hm.fr
Contact Person Name
Laetitia Dahan
Contact Person Email
laetitia.dahan@ap-hm.fr
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie médicale
Principal Investigator Name
Claire Jaraudias
Principal Investigator Email
Claire.JARAUDIAS@nice.unicancer.fr
Contact Person Name
Claire Jaraudias
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie digestive
Principal Investigator Name
Denis Smith
Principal Investigator Email
denis.smith@chu.bordeaux.fr
Contact Person Name
Denis Smith
Contact Person Email
denis.smith@chu.bordeaux.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Oncologie médicale
Principal Investigator Name
Olivier Dubreuil
Principal Investigator Email
odubreuil@hopital-dcss.org
Contact Person Name
Olivier Dubreuil
Contact Person Email
odubreuil@hopital-dcss.org
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie médicale
Principal Investigator Name
Marc Pracht
Principal Investigator Email
m.pracht@rennes.unicancer.fr
Contact Person Name
Marc Pracht
Contact Person Email
m.pracht@rennes.unicancer.fr

Belgium

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
46
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Digestive Oncology
Principal Investigator Name
Timon Vandamme
Principal Investigator Email
Timon.vandamme@uza.be
Contact Person Name
Timon Vandamme
Contact Person Email
Timon.vandamme@uza.be
Site Name
UZ Leuven
Department Name
Digestive Oncology
Principal Investigator Name
Filip Van Herpe
Principal Investigator Email
filip.vanherpe@uzleuven.be
Contact Person Name
Filip Van Herpe
Contact Person Email
filip.vanherpe@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Gastroenterology
Principal Investigator Name
Karen Geboes
Principal Investigator Email
karen.geboes@uzgent.be
Contact Person Name
Karen Geboes
Contact Person Email
karen.geboes@uzgent.be

Germany

Earliest CTIS Part Ii Submission Date
06-10-2025
Latest Decision Or Authorization Date
30-10-2025
Processing Time Days
24
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Principal Investigator Name
Leonidas Apostolidis
Principal Investigator Email
leonidas.apostolidis@med.uni-heidelberg.de
Contact Person Name
Leonidas Apostolidis
Site Name
Asklepios Klinik St George
Department Name
Asklepios proresearch
Principal Investigator Name
Sebastian Maasberg
Principal Investigator Email
s.maasberg@asklepios.com
Contact Person Name
Sebastian Maasberg
Contact Person Email
s.maasberg@asklepios.com
Site Name
Philipps-Universitaet Marburg
Department Name
Interal medicine, SP Gastroenterology
Principal Investigator Name
Anja Rinke
Principal Investigator Email
sprengea@uni-marburg.de
Contact Person Name
Anja Rinke
Contact Person Email
sprengea@uni-marburg.de
Site Name
Technische Universitaet Dresden
Department Name
Universitätsklinikum Carl Gustav Carus Dresden
Principal Investigator Name
Anke Kröcher
Principal Investigator Email
anke.kroecher@ukdd.de
Contact Person Name
Anke Kröcher
Contact Person Email
anke.kroecher@ukdd.de
Site Name
Zentralklinik Bad Berka GmbH
Department Name
Klinik für Innere Medizin/Gastroenterologie und Endokrinologie
Principal Investigator Name
Dieter Hörsch
Principal Investigator Email
dieter.hoersch@zentralklinik.de
Contact Person Name
Dieter Hörsch
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Endokrinologie, Diabetologie und Stoffwechsel
Principal Investigator Name
Harlad Lahner
Principal Investigator Email
harlad.lahner@uk-essen.de
Contact Person Name
Harlad Lahner
Contact Person Email
harlad.lahner@uk-essen.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
I. Medizinische Klinik und Poliklinik
Principal Investigator Name
Thorben Fründt
Principal Investigator Email
tfruendt@uke.de
Contact Person Name
Thorben Fründt
Contact Person Email
tfruendt@uke.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Med. Klinik II Gastroenterologie
Principal Investigator Name
Alexander Weich
Principal Investigator Email
weich_a@ukw.de
Contact Person Name
Alexander Weich
Contact Person Email
weich_a@ukw.de

Ireland

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
14-11-2025
Processing Time Days
30
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
St Vincent's University Hospital
Department Name
Medical Oncology
Principal Investigator Name
Mark Doherty
Principal Investigator Email
markdoherty@svhg.ie
Contact Person Name
Mark Doherty
Contact Person Email
markdoherty@svhg.ie

Romania

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
32
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Medical
Principal Investigator Name
Raluca Mihaila
Principal Investigator Email
raluca.mihaila.ext@arensia-em.com
Contact Person Name
Raluca Mihaila
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical
Principal Investigator Name
Eliade Tudor Ciuleanu
Principal Investigator Email
tudor.ciuleanu.ext@arensia-em.com
Contact Person Name
Eliade Tudor Ciuleanu

Italy

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
12
Number Of Sites
9
Number Of Participants
16

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Unit of Oncological Endocrinology - Medical Sciences
Principal Investigator Name
Emanuela Arvat
Principal Investigator Email
emanuela.arvat@unito.it
Contact Person Name
Emanuela Arvat
Contact Person Email
emanuela.arvat@unito.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Department of Oncology and Haematology
Principal Investigator Name
Gelsomino Fabio
Principal Investigator Email
gelsomino.fabio@aou.mo.it
Contact Person Name
Gelsomino Fabio
Contact Person Email
gelsomino.fabio@aou.mo.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Department of Medical and Surgical Sciences
Principal Investigator Name
Davide Campana
Principal Investigator Email
davide.campana@unibo.it
Contact Person Name
Davide Campana
Contact Person Email
davide.campana@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Medical Surgical Sciences and Translational Medicine - Diseases Unit
Principal Investigator Name
Francesco Panzuto
Principal Investigator Email
francesco.panzuto@uniroma1.it
Contact Person Name
Francesco Panzuto
Contact Person Email
francesco.panzuto@uniroma1.it
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
Department of Interdisciplinary Medicine
Principal Investigator Name
Mauro Cives
Principal Investigator Email
mauro.civ@tiscali.it
Contact Person Name
Mauro Cives
Contact Person Email
mauro.civ@tiscali.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Endocrinologia, Diabetologia e Andrologia
Principal Investigator Name
Andrea Lania
Principal Investigator Email
andrea.lania@hunimed.eu
Contact Person Name
Andrea Lania
Contact Person Email
andrea.lania@hunimed.eu
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
Principal Investigator Name
Francesca Spada
Principal Investigator Email
francesca.spada@ieo.it
Contact Person Name
Francesca Spada
Contact Person Email
francesca.spada@ieo.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SCDU Medical Oncology
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Internal Medicine, Endocrinology and Diabetes Unit, Department of Medical and Surgical Sciences
Principal Investigator Name
Antonio Bianchi
Principal Investigator Email
antonio.bianchi@policlinicogemelli.it
Contact Person Name
Antonio Bianchi

Spain

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
31-07-2025
Processing Time Days
13
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Rocio Garcia Carbonero
Principal Investigator Email
rgcarbonero@gmail.com
Contact Person Name
Rocio Garcia Carbonero
Contact Person Email
rgcarbonero@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Jorge Hernando Cubero
Principal Investigator Email
jhernando@vhio.net
Contact Person Name
Jorge Hernando Cubero
Contact Person Email
jhernando@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Marta Benavent Viñuales
Principal Investigator Email
martabenaventv@gmail.com
Contact Person Name
Marta Benavent Viñuales
Contact Person Email
martabenaventv@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Maria Gabriela Torres Perez-Solero
Principal Investigator Email
gabrielatps@gmail.com
Contact Person Name
Maria Gabriela Torres Perez-Solero
Contact Person Email
gabrielatps@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Teresa Alonso Gordoa
Principal Investigator Email
talonsogordoa@gmail.com
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
talonsogordoa@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Angela Lamarca Lete
Principal Investigator Email
angela.lamarca@quironsalud.es
Contact Person Name
Angela Lamarca Lete
Contact Person Email
angela.lamarca@quironsalud.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Oncology
Principal Investigator Name
Maria Isabel Sevilla Garcia
Principal Investigator Email
isevilla02@yahoo.es
Contact Person Name
Maria Isabel Sevilla Garcia
Contact Person Email
isevilla02@yahoo.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Maria Isabel del Olmo Garcia
Principal Investigator Email
maribeldelolmo@gmail.com
Contact Person Name
Maria Isabel del Olmo Garcia
Contact Person Email
maribeldelolmo@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
03-07-2025
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
32
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Centrum Diagnostyczno-Lecznicze
Principal Investigator Name
Agnieszka Kolasinska - Ćwikła
Principal Investigator Email
adkolasinska@yahoo.com
Contact Person Name
Agnieszka Kolasinska - Ćwikła
Contact Person Email
adkolasinska@yahoo.com
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Endokrynologii i Nowotworów Neuroendokrnych
Principal Investigator Name
Beata Kos-Kudła
Principal Investigator Email
endoklin@sum.edu.pl
Contact Person Name
Beata Kos-Kudła
Contact Person Email
endoklin@sum.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Klinika Endokrynologii, Przemiany Materii i Chorób Wewnętrznych
Principal Investigator Name
Marek Ruchala
Principal Investigator Email
endosk2@ump.edu.pl
Contact Person Name
Marek Ruchala
Contact Person Email
endosk2@ump.edu.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Endokrynologii i Terapii Izotopowej
Principal Investigator Name
Grzegorz Kaminski
Principal Investigator Email
gkaminski@wim.mil.pl
Contact Person Name
Grzegorz Kaminski
Contact Person Email
gkaminski@wim.mil.pl

Sponsor

Primary sponsor

Full Name
Crinetics Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
Paltusotine 40 mg tablets
Active Substance
PALTUSOTINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Starting Dose
40 mg (tablet)
Dose Levels
40 mg (tablet); maximum daily 80 mg (product metadata lists maxDailyDoseAmount 80 mg)
Frequency
daily
Maximum Dose
80 mg per day
Investigational Product Name
Placebo, Paltusotine 40 mg tablets
Modality
Other

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