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 )
Recruiting
Phase 3
Interventional Study
Pancreatic Cancer
Pancreatic Cancer Metastatic
PDAC
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Ductal Adenocarcinoma (PDAC)
Pancreatic Adenocarcinoma Metastatic
Pancreatic Adenocarcinoma
Pancreatic Adenosquamous Carcinoma
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 670 (estimated)
- Sponsor
- Revolution Medicines, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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.
* Documente…
Contacts