A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
Recruiting
Phase 3
Interventional Study
Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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
- 588 (estimated)
- Sponsor
- Incyte Corporation · Industry
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About This Trial
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation
* No prior systemic treatment in the metastatic setting
* ECOG Performance status 0-1
* Adequate organ function
Exclusion Criteria:
* Prior treatment with any KRAS inhibitor
* Chronic or curr…
Contacts