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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two years after treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
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%
Cough
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
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%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Sinusitis
17%
Upper respiratory infection
17%
Peripheral sensory neuropathy
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
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%
Blurred vision
7%
Skin infection
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Death
6%
Cataract
6%
Dehydration
6%
Knee pain
6%
Itchy skin
6%
Psoriasis
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%
Back spasms
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Burn
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Sinus pain
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal 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%
Intrascapular pain
2%
Hemorrhoids
2%
Sinus tachycardia
2%
Pharyngitis
2%
Puncture wound
2%
Radiation recall reaction (dermatologic)
2%
Activated partial thromboplastin time prolonged
2%
Erythema right breast
2%
Hypermagnesemia
2%
Vaginal discharge
2%
Leg pain
2%
Wrist fracture
2%
Erythema multiforme
2%
Cold sweats
2%
Paronychia
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Facial nerve disorder
2%
Paresthesia
2%
Urinary retention
2%
Hyperuricemia
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
COPD
2%
Fracture
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
2%
Bilateral nares sores
2%
Lung cancer
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%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
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
~3760

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,288 Total Patients Enrolled
4 Trials studying Melanoma
80 Patients Enrolled for Melanoma
BioMed Valley Discoveries, IncIndustry Sponsor
16 Previous Clinical Trials
693 Total Patients Enrolled
1 Trials studying Melanoma
13 Patients Enrolled for Melanoma
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,937 Total Patients Enrolled
51 Trials studying Melanoma
49,408 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions can Ulixertinib be used to alleviate?

"Ulixertinib is often prescribed to treat breast conditions, yet it has also been demonstrated as a viable treatment option for malignant neoplasms, postmenopause cases and even complex advance directives."

Answered by AI

Who has the eligibility to partake in this medical study?

"This clinical trial is open to 45 participants afflicted with pancreatic cancer, all of whom must be 18 years or older. Key requirements for eligibility include providing written informed consent and HIPAA authorization, having an Eastern Cooperative Oncology Group Performance Status no greater than 2, exhibiting measurable or non-measurable (but evaluable) disease according to RECIST v1.1 guidelines depending on the cohort they are in, demonstrating life expectancy of at least 12 weeks as well as recovered from reversible acute toxic effects of anti-cancer treatment up to Grade 1 toxicity or baseline levels respectively; hemoglobin ≥ 9 g/dL, absolute neutrophil"

Answered by AI

Are there any enrolment opportunities open for this investigation at present?

"Affirmative, according to the clinicaltrials.gov website, this trial is recruiting now. It was first made public on January 30th 2018 and recently updated on November 18th 2022. A total of 45 participants are needed from a single location for enrolment."

Answered by AI

How many participants are engaged in this experimentation?

"Affirmative. According to the information on clinicaltrials.gov, this investigation is still searching for individuals to participate in the study which was initially published on January 30th 2018 and last modified November 18th 2022. 45 applicants are required from 1 medical site."

Answered by AI

Is this experiment open to participants aged 55 and up?

"The eligibility criteria for this clinical trial stipulates that only those between 18 to 99 years of age can enroll. Subsequently, there are separate trials available for individuals below the age of 18 and people beyond 65."

Answered by AI

Are there any precedent studies that have utilized Ulixertinib?

"As of now, 137 clinical trials are underway that evaluate the effects of Ulixertinib. Of those, 16 have reached Phase 3 and a significant number (6715) of medical centres worldwide aid in these studies. The majority are located in Burgas, New jersey."

Answered by AI

Has Ulixertinib been granted sanction from the Food and Drug Administration?

"There is a dearth of evidence to back up the safety and efficacy of Ulixertinib, so it was given a rating of 1 on our team's scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
2018. "Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03454035.
All > Pancreatic Cancer > Melanoma
~1 spots leftby Jul 2024
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