OncoMatch/Clinical Trials/NCT03454035
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Is NCT03454035 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Ulixertinib and Palbociclib for tumor, solid.
Treatment: Ulixertinib · Palbociclib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Pancreatic Cancer
Melanoma
Biomarker criteria
Required: NRAS G12 mutation
NRASG12/G13/Q61
Required: NRAS G13 mutation
NRASG12/G13/Q61
Required: NRAS Q61 mutation
NRASG12/G13/Q61
Required: KRAS G12 mutation
KRASG12/G13
Required: KRAS G13 mutation
KRASG12/G13
Required: HRAS G12 mutation
HRASG12/G13
Required: HRAS G13 mutation
HRASG12/G13
Required: NRAS amplification
any amplifications of the NRAS, KRAS, or HRAS genes
Required: KRAS amplification
any amplifications of the NRAS, KRAS, or HRAS genes
Required: HRAS amplification
any amplifications of the NRAS, KRAS, or HRAS genes
Required: NF1 loss-of-function mutation
subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled
Required: BRAF wild-type
subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: any prior therapy — metastatic
patients who have received at least one line of therapy in the metastatic setting
Must have received: anti-PD-1 therapy
disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug
Cannot have received: cancer-directed therapy
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
Lab requirements
Blood counts
Hemoglobin (Hgb) ≥ 9 g/dL; ANC ≥ 1,500 /mm3; Platelets ≥ 100,000/mm3
Kidney function
Creatinine ≤1.5 x ULN or Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula
Liver function
Bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN
Cardiac function
LVEF >50% by ECHO; QTc <470ms
Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to day -6 of ulixertinib Hemoglobin (Hgb) ≥ 9 g/dL Absolute Neutrophil Count (ANC) ≥ 1,500 /mm3 Platelets ≥ 100,000/mm3 Creatinine ≤1.5 x upper limit of normal (ULN) or Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula Bilirubin ≤ 1.5 x ULN Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN Adequate cardiac function; left ventricular ejection fraction (LVEF) >50% as assessed by ultrasound/echocardiography (ECHO); corrected QT interval (QTc) <470ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03454035 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cancer-directed therapy disqualifies patients from enrollment.
Does this trial require NRAS?
Yes, NRAS G12 mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS G13 mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS Q61 mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify