Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 ) (RASolute 305)
RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with Investigator choice of chemotherapy will improve progression-free survival or overall survival compared to placebo in combination with Investigator choice of chemotherapy when given to patients with previously untreated, 1L metastatic KRAS G12D-mutated pancreatic adenocarcinoma. Choice of chemotherapy (mFFX or GnP) will be at the discretion of the Investigator.
Patients will be randomized to one of two arms: zoldonrasib + Investigator choice of chemotherapy (Arm A) or placebo + Investigator choice of chemotherapy (Arm B).
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Revolution Medicines Study Director
- Telefonnummer: 1-844-2-REVMED
- E-post: medinfo@revmed.com
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Rekruttering
- Mayo Clinic Arizona
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Ta kontakt med:
- Bekaii-Saab
- Telefonnummer: 855-776-0015
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Tucson, Arizona, Forente stater, 85719
- Rekruttering
- The University of Arizona Cancer Center-North Campus
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Ta kontakt med:
- Zimmerman
- Telefonnummer: 520-626-8286
- E-post: priscaz@arizona.edu
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Connecticut
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New Haven, Connecticut, Forente stater, 06511
- Rekruttering
- Yale University
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Ta kontakt med:
- Boateng
- Telefonnummer: 203-314-7948
- E-post: Kwasi.boateng@yale.edu
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Florida
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Gainesville, Florida, Forente stater, 32610
- Rekruttering
- University of Florida
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Ta kontakt med:
- Allegra
- Telefonnummer: 352-294-5691
- E-post: allisonallegra3@ufl.edu
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Ta kontakt med:
- Barnes
- Telefonnummer: 352-273-8020
- E-post: j.barnes1@ufl.edu
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Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- Mayo Clinic Florida
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Ta kontakt med:
- Babiker
- Telefonnummer: 855-776-0015
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffitt Cancer Center
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Ta kontakt med:
- Kim
- Telefonnummer: 813-745-3691
- E-post: Cheyenne.Schneider@moffitt.org
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Georgia
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Atlanta, Georgia, Forente stater, 30318
- Rekruttering
- Piedmont Cancer Institute
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Ta kontakt med:
- Adams
- Telefonnummer: 678-298-3238
- E-post: kadams@piedmontcancerinstitute.com
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Atlanta, Georgia, Forente stater, 30318
- Rekruttering
- Piedmont Healthcare
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Ta kontakt med:
- Mieri
- Telefonnummer: 404-425-1777
- E-post: Takiyyah.Hamilton@piedmont.org
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Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago Medical Center
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Ta kontakt med:
- Desgardin
- Telefonnummer: 773-834-7188
- E-post: adesgard@bsd.uchicago.edu
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- Johns Hopkins University
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Ta kontakt med:
- Apostol
- Telefonnummer: 410-502-7484
- E-post: giclinicaltrials@jhmi.edu
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Dana Farber Cancer Institute
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Ta kontakt med:
- Lindquist
- Telefonnummer: 857-215-2351
- E-post: DanielleA_Lindquist@DFCI.HARVARD.EDU
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- Mayo Clinic Rochester
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Ta kontakt med:
- Jazieh
- Telefonnummer: 855-776-0015
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New Jersey
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East Brunswick, New Jersey, Forente stater, 08816
- Rekruttering
- Astera Cancer Care
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Ta kontakt med:
- Yao
- Telefonnummer: ext 1012 732-390-7750
- E-post: eileen.peng@asterahealthcare.org
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New Brunswick, New Jersey, Forente stater, 08901
- Rekruttering
- Rutgers Cancer University
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Ta kontakt med:
- DiOrio
- Telefonnummer: 732-235-2135
- E-post: kassie.diorio@rutgers.edu
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New York
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New York, New York, Forente stater, 10032
- Rekruttering
- Columbia University Irving Medical Center
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Ta kontakt med:
- Manji
- Telefonnummer: 212-342-5162
- E-post: cancerclinicaltrials@cumc.columbia.edu
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Duke Cancer Center
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Ta kontakt med:
- Currier
- Telefonnummer: 919-668-1861
- E-post: gi-oncology-cru@dm.duke.edu
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt-Ingram Cancer Center
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Ta kontakt med:
- Cardin
- Telefonnummer: 800-811-8480
- E-post: cip@vumc.org
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Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- University of Texas MD Anderson Cancer Center
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Ta kontakt med:
- Ross
- Telefonnummer: 713-794-1623
- E-post: GIClinicalTrials@mdanderson.org
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Florence, Italia, 50134
- Rekruttering
- Azienda Ospedaliera Universitaria Careggi
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Padova, Italia, 35128
- Rekruttering
- Instituto Oncologico Veneto - IRCCS
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Nijmegen, Nederland, 6525
- Rekruttering
- Radboud UMC
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London, Storbritannia, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital
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London, Storbritannia, EC1A 7BE
- Rekruttering
- St Bartholomew's Hospital - Barts Health NHS Trust
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London, Storbritannia, W12 0HS
- Rekruttering
- Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital
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Salzburg, Østerrike, 05020
- Rekruttering
- Universitatsklinikum der PMU Salzburg Landeskrankenhaus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed pancreatic adenocarcinoma.
- Diagnosis of metastatic disease ≤ 6 weeks prior to screening.
- Documented KRAS G12D mutation status.
- Measurable disease per RECIST v1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation).
- Able to take oral medications.
Exclusion Criteria:
- Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.
- Prior systemic RAS-targeted therapy any time prior to randomization.
- Presence of other known driver mutations with approved targeted therapies
- Active or known history of untreated central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study drug.
- Major surgery within 28 days prior to randomization.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP) |
IV infusion oral tablets IV infusion IV infusion IV infusion IV infusion IV infusion |
|
Placebo komparator: Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP) |
IV infusion IV infusion IV infusion IV infusion IV infusion IV infusion oral tablets |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression free survival (PFS)
Tidsramme: Up to approximately 4 years
|
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by Investigator. |
Up to approximately 4 years
|
|
Overall survival (OS)
Tidsramme: Up to approximately 4 years
|
OS is defined as the time from randomization until death from any cause. |
Up to approximately 4 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS per blinded independent central review (BICR)
Tidsramme: Up to approximately 4 years
|
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed RECIST v1.1 by BICR. |
Up to approximately 4 years
|
|
Objective response rate (ORR)
Tidsramme: Up to approximately 4 years
|
Objective response is defined as partial response (PR) or complete response (CR) as assessed per RECIST v1.1 by Investigator and BICR. |
Up to approximately 4 years
|
|
Duration of response (DOR)
Tidsramme: Up to approximately 4 years
|
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator and BICR. |
Up to approximately 4 years
|
|
Incidence of adverse events (AEs)
Tidsramme: Up to approximately 4 years
|
Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 |
Up to approximately 4 years
|
|
Changes in vital signs
Tidsramme: Up to approximately 4 years
|
Number of patients with clinically significant changes in vital signs. |
Up to approximately 4 years
|
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Changes in clinical laboratory test values
Tidsramme: Up to approximately 4 years
|
Number of patients with changes from baseline in clinical laboratory test values |
Up to approximately 4 years
|
|
Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) pain scale
Tidsramme: Up to approximately 4 years
|
EORTC QLQ-PAN26 consists of 26 questions relating to disease symptoms, treatment side effects and emotional issues specific to pancreatic cancer. The pancreatic pain subscale assesses abdominal pain, back pain, and pain while lying down. Change in score from baseline in the pain subscale will be assessed with higher scores on the pain subscale indicating more severe pain and worsening function. |
Up to approximately 4 years
|
|
Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status score
Tidsramme: Up to approximately 4 years
|
EORTC QLQ-C30 consists of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. It uses a mix of 4-point scales and 7-point scales. Change from baseline in EORTC QLQ-C30 global health status will be assessed. Higher scores on functional scales reflect better functioning, whereas higher scores on symptom scales reflect higher symptom burden. |
Up to approximately 4 years
|
|
Concentration of zoldonrasib in Arm A
Tidsramme: Up to Cycle 5 Day 1 (each cycle is 28 days)
|
Pre-dose trough and post-dose blood concentrations of zoldonrasib at selected visits. |
Up to Cycle 5 Day 1 (each cycle is 28 days)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
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