← Back to Search

CDK4/6 Inhibitor

Ulixertinib + Palbociclib for Pancreatic Cancer

Phase 1
Recruiting
Led By Autumn McRee, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented disease refractory to at least one PD1/PD-L1 inhibitor
Metastatic pancreatic cancer or malignant melanoma patients who have received at least one line of therapy in the metastatic setting
Must not have
Unable or unwilling to discontinue use of certain drugs known to interact with study medications
Major surgery within 28 days prior to day -6 of ulixertinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years after treatment
Awards & highlights

Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?
Adults with advanced solid tumors, including pancreatic cancer or melanoma that's resistant to standard treatments. Participants must have an ECOG Performance Status of ≤2, a life expectancy ≥12 weeks, and adequate organ function. Women who can bear children need a negative pregnancy test and agree to use contraception.
What is being tested?
The trial is testing the combination of ulixertinib (an ERK inhibitor) with palbociclib (a CDK4/6 inhibitor) to find the safest dose with tolerable side effects for patients with specific types of advanced cancers.
What are the potential side effects?
Potential side effects are not specified in this summary but generally could include fatigue, nausea, diarrhea, blood count changes, and other drug-specific reactions based on their action on enzymes and cell cycle inhibition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition did not improve after treatment with a PD1/PD-L1 inhibitor.
Select...
I have pancreatic cancer or melanoma and have been treated for it after it spread.
Select...
My melanoma cannot be removed by surgery and is in stage III or IV with certain genetic changes.
Select...
I have been treated with ipilimumab before.
Select...
My heart is strong, with a good pumping ability and normal heart rhythm.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My advanced cancer does not respond to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot or will not stop taking drugs that could affect the study medication.
Select...
I have not had major surgery within the last 34 days.
Select...
I have a digestive issue that affects how my body absorbs medicine.
Select...
I have an autoimmune disease and take steroids for it.
Select...
I have or am at risk for eye conditions like RVO or CSR.
Select...
I have another cancer that is growing and needs treatment.
Select...
My cancer has spread to my brain under certain conditions.
Select...
I cannot swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment completion, approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through treatment completion, approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD)
Secondary study objectives
Cancer Antigen 19-9 (CA19-9) response
Objective Response Rate
Overall Survival
+2 more

Side effects data

From 2023 Phase 2 trial • 55 Patients • NCT03007979
96%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Hyponatremia
35%
Arthralgia
35%
Cough
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hypercalcemia
31%
Hyperkalemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Dysgeusia
20%
Hyperglycemia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Fever
17%
Upper respiratory infection
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Hypophosphatemia
9%
Epistaxis
9%
COVID-19
9%
Dysphagia
7%
Vertigo
7%
Non-cardiac chest pain
7%
Skin infection
7%
Blurred vision
7%
Tooth infection
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Knee pain
6%
Dehydration
6%
Psoriasis
6%
Itchy skin
6%
Death
6%
Cellulitis
6%
Cataract
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Broken tooth
4%
Burn
4%
Back spasms
4%
Abdominal pain
4%
Head injury
4%
Skin bump
4%
Memory impairment
4%
Vaginal dryness
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Watering eyes
4%
Dry eye
4%
Edema trunk
4%
Flu-like symptoms
4%
Sinus pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Activated partial thromboplastin time prolonged
2%
Photophobia
2%
Cold sweats
2%
Localized edema
2%
Blood bilirubin increased
2%
Agitation
2%
Gait disturbance
2%
Urinary retention
2%
Wrist pain
2%
Bladder infection
2%
Diverticulitis
2%
Cognitive disturbance
2%
Eye lid pain
2%
Sinus tachycardia
2%
Fracture
2%
Nail loss
2%
Respiratory syncytial virus (RSV)
2%
Hemorrhoids
2%
Paronychia
2%
Flank pain
2%
Lung cancer
2%
Paresthesia
2%
Urine discoloration
2%
Vaginal discharge
2%
Oral fissure
2%
Shoulder nodule
2%
Vaginal itching
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Wrist fracture
2%
Hypermagnesemia
2%
Facial nerve disorder
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
Hyperuricemia
2%
Sepsis
2%
Pharyngitis
2%
Generalized weakness
2%
Red eye
2%
C. difficile
2%
Groin pain
2%
Puncture wound
2%
Intrascapular pain
2%
Leg pain
2%
Fungal toe infection
2%
Rhinovirus
2%
Yeast infection
2%
Radiation recall reaction (dermatologic)
2%
Myocardial infarction
2%
Vaginal infection
2%
Wound infection
2%
COPD
2%
Hoarseness
2%
Laryngeal inflammation
2%
Sinus congestion
2%
Bilateral nares sores
2%
Erythema multiforme
2%
Erythema right breast
2%
Fever blister
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label, single arm Phase IExperimental Treatment2 Interventions
Ulixertinib added to palbociclib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulixertinib
2020
Completed Phase 1
~20
Palbociclib
2017
Completed Phase 3
~3880

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
89,850 Total Patients Enrolled
4 Trials studying Melanoma
80 Patients Enrolled for Melanoma
BioMed Valley Discoveries, IncIndustry Sponsor
17 Previous Clinical Trials
566 Total Patients Enrolled
1 Trials studying Melanoma
13 Patients Enrolled for Melanoma
PfizerIndustry Sponsor
4,625 Previous Clinical Trials
14,284,149 Total Patients Enrolled
53 Trials studying Melanoma
49,652 Patients Enrolled for Melanoma

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03454035 — Phase 1
Melanoma Research Study Groups: Open-label, single arm Phase I
Melanoma Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT03454035 — Phase 1
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03454035 — Phase 1
~5 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top