Trial NCT07621718
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 )
- Phase
- Phase 3
- Sponsor
- Revolution Medicines, Inc.
- Conditions
- Pancreatic Cancer; Pancreatic Cancer Metastatic; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Adenocarcinoma Metastatic; Pancreatic Adenocarcinoma; Pancreatic Adenosquamous Carcinoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Performance status
* 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.Brain metastases
* 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.
Restrictions found (2)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text
Recruiting in Massachusetts
- Dana Farber Cancer Institute · Boston, Suffolk County