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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
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
No Placebo-Only Group

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
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My condition did not improve after treatment with a PD1/PD-L1 inhibitor.
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I have pancreatic cancer or melanoma and have been treated for it after it spread.
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My melanoma cannot be removed by surgery and is in stage III or IV with certain genetic changes.
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I have been treated with ipilimumab before.
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My heart is strong, with a good pumping ability and normal heart rhythm.
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I can take care of myself but might not be able to do heavy physical work.
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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:
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I cannot or will not stop taking drugs that could affect the study medication.
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I have not had major surgery within the last 34 days.
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I have a digestive issue that affects how my body absorbs medicine.
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I have an autoimmune disease and take steroids for it.
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I have or am at risk for eye conditions like RVO or CSR.
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I have another cancer that is growing and needs treatment.
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My cancer has spread to my brain under certain conditions.
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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 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Diarrhea
17%
Mucositis
17%
Headache
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Cough
11%
Anemia
11%
Upper respiratory infection
10%
Flu like symptoms
10%
Obesity
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Dizziness
7%
Dyspepsia
7%
Pruritus
7%
Hot flashes
7%
Bone pain
5%
Dysgeusia
5%
Pain
3%
Respiratory infection
3%
Nail disorder
3%
Abdominal pain
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Bronchial infection
1%
Spinal cord compression
1%
Heart failure
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Osteonecrosis of jaw
1%
Pleural effusion
1%
Renal failure
1%
Thromboembolic event
1%
Urinary tract infection
1%
Dislocation of hip
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1: Palbociclib Plus Exemestane
Cohort 1 and 2: Capecitabine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
361 Previous Clinical Trials
90,405 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
4,640 Previous Clinical Trials
17,741,096 Total Patients Enrolled
53 Trials studying Melanoma
49,541 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
~4 spots leftby Aug 2025
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