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Peak - A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors.

Studio Clinico

Patologia: Sarcomi dei tessuti molli e gist

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

1- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization.
2- Documented disease progression on or intolerance to imatinib
3- Subjects must have received the following treatment:
    - Part 1a: Treatment with ≥1 prior lines of therapy for GIST
    - Part 1b: Treatment with ≥2 prior TKI for GISTs
    - Part 2: Prior treatment with imatinib only
4- Have at least 1 measurable lesion according to mRECIST v1.1
5- ECOG - 0 to 2
6- Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.

Criteri di esclusione: 

1- Known PDGFR driving mutations or known succinate dehydrogenase deficiency
2- Clinically significant cardiac disease
3- Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
4- Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
5- Any active bleeding excluding hemorrhoidal or gum bleeding
6- Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
7- Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
8- Received strong CYP3A4 inhibitors or inducers
9- Received sunitinib within 3 weeks (Part 1a, Part 1b).

Schema di trattamento: 

Arm  Intervention/treatment
Experimental: Part 1a
CGT9486 plus sunitinib 37.5 mg QD
Drug: CGT9486 plus sunitinib
Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
Experimental: Part 2 - Experimental Group
CGT9486 plus sunitinib 37.5 mg QD
Drug: CGT9486 plus sunitinib
Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
Active Comparator: Part 2 - Control Group
sunitinib 37.5 mg QD
Drug: Sunitinib
Participants will receive sunitinib orally until study stopping rules are met.
Other Name: sunitinib - Part 2
Experimental: Part 1b - DDI Cohort 1
CGT9486 plus sunitinib 37.5 mg QD
Drug: CGT9486
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
Experimental: Part 1b - DDI Cohort 2
sunitinib 37.5 mg QD plus CGT9486
Drug: Sunitinib
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
Other Name: sunitinib - Part 1b

Trattamento sperimentale: 

CGT9486 plus sunitinib

Trattamento di controllo: 

sunitinib 

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

 

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

 

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

 

AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

 

Università Campus Bio-medico
Via Álvaro del Portillo 200 - 00128 Roma - RM

 

Sud Italia e isole

AOU Policlinico Paolo Giaccone
Via del Vespro 129 - 90127 Palermo - PA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT05208047

Data di inserimento: 09.02.2024

Promotore

Cogent Biosciences, Inc.

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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