Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
Eligibility criteria
Qualifiers
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent (no upper age limit)
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care
Disqualifiers
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)
Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib
A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
Major surgery within 28 days prior to day -6 of ulixertinib
Trial design
Treatments tested in this trial
- Ulixertinib
- Palbociclib
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
BioMed Valley Discoveries, Inc
Collaborator
Pfizer
Collaborator
Source ClinicalTrials.gov