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MEK/ERK Inhibitor
Targeted Drug Therapy for Pancreatic Cancer
Phase < 1
Recruiting
Led By Charles D Lopez
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights
Summary
This trial is testing four experimental drugs to see if they can help treat pancreatic cancer. The drugs work by blocking important processes that cancer cells need to grow and survive. The trial focuses on patients with pancreatic cancer who do not respond well to standard treatments. Gemcitabine was the first agent investigated for its potential to improve symptoms and overall well-being in pancreatic cancer patients.
Who is the study for?
Adults (18+) with pancreatic cancer, either resectable or metastatic adenocarcinoma, who can consent to treatment and biopsies. They may be new to treatment or have had prior therapy with a specific washout period. Good organ function is required, and they must not be pregnant or breastfeeding. Contraception use is necessary for participants of childbearing potential.
What is being tested?
The trial tests the effectiveness of cobimetinib, olaparib, LY3214996 (temuterkib), and onvansertib in treating pancreatic cancer by comparing tissue samples before and after treatment. It's an early phase I trial designed to inform future trials based on biomarkers.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs' components, digestive issues due to oral administration challenges, increased risk of infection, blood disorders from bone marrow suppression, liver toxicity indicated by elevated enzymes levels in the blood.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of all pharmacodynamic feasibility-evaluable participants within a study arm that have a measurable change in post-treatment tumor biology from baseline
Secondary study objectives
Incidence of >= grade 3 toxicities for each assigned window treatment (as described in sub-protocol)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Arm VII (tremelimumab)Experimental Treatment1 Intervention
Patients receive tremelimumab IV over 60 minutes one-time. Within 12-24 hours of cycle completion, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Group II: Arm VI (AZD5305)Experimental Treatment1 Intervention
Patients receive AZD5305 PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Group III: Arm V (azenosertib)Experimental Treatment1 Intervention
Patients receive azenosertib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Group IV: Arm IV (onvansertib)Experimental Treatment1 Intervention
Patients receive onvansertib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Group V: Arm II (cobimetinib)Experimental Treatment1 Intervention
Patients receive cobimetinib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Group VI: Arm I (olaparib)Experimental Treatment1 Intervention
Patients receive olaparib PO BID on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3130
Onvansertib
2017
Completed Phase 2
~220
Cobimetinib
2017
Completed Phase 3
~3300
Olaparib
2007
Completed Phase 4
~2190
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cobimetinib is a MEK inhibitor that blocks the MEK/ERK pathway, which is often overactive in cancer cells, leading to uncontrolled growth. Olaparib is a PARP inhibitor that prevents cancer cells from repairing their DNA, causing them to die, especially effective in tumors with BRCA mutations.
LY3214996 is an ERK inhibitor that targets the ERK protein, a downstream component of the MEK/ERK pathway, further inhibiting cancer cell proliferation. Onvansertib is a PLK1 inhibitor that disrupts cell division, leading to cancer cell death.
These targeted therapies are important for pancreatic cancer patients as they offer more personalized and potentially more effective treatment options based on the specific characteristics of their cancer.
Find a Location
Who is running the clinical trial?
American Association for Cancer ResearchOTHER
8 Previous Clinical Trials
742 Total Patients Enrolled
Cardiff OncologyIndustry Sponsor
10 Previous Clinical Trials
539 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
234 Previous Clinical Trials
2,088,537 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that affects my ability to swallow or absorb pills.I am not pregnant or breastfeeding.I am not taking strong or moderate drugs that affect liver enzymes.My health conditions make surgery too risky according to hospital standards.I don't have lasting side effects from past treatments, except for possible mild nerve issues, hair loss, or skin color changes.My cancer can potentially be cured with surgery.I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.I agree to use birth control as required by the OLAPARIB study.I have previously been treated with a PLK1 inhibitor for my condition.I do not have an ongoing serious infection that isn't getting better with treatment.My tumor cannot be biopsied with a core needle.I am willing and able to follow the study's treatment and visit schedule.I do not have serious heart disease or poor heart function.I am not taking strong or moderate drugs that affect liver enzymes.I can take care of myself and am up and about more than half of my waking hours.My kidney function is within the required range.My hemoglobin level is at least 9.0 g/dL without recent blood transfusions.I have pancreatic cancer and if treated before, I've had a 10-day break from my last therapy.I am 18 years old or older.I am willing to have tumor biopsies during the study.I can swallow pills without any issues.I have never been treated with a WEE1 inhibitor.I don't have lasting side effects from previous treatments, except for mild neuropathy, hair loss, or skin color changes.I have a tumor that can be safely biopsied according to hospital rules.I have no cancer history, except for certain skin, breast, or cervical cancers treated over 6 months ago.I don't have a personal or family history of long QT syndrome or Torsade de Pointes.I am not using strong CYP3A4/UGT1A1 inhibitors or inducers, or I can switch to another therapy.I am not taking any medications that increase the risk of heart rhythm problems, or if I am, I'm monitored closely.I don't have active hepatitis B, may have treated hepatitis C, and if I have HIV, it's well-managed.I am not eligible for cobimetinib due to specific criteria.My kidney function, measured by creatinine clearance, is within or above the normal range.I am not allergic to drugs similar to ZN-c3.I am not using other cancer treatments or strong medications that affect enzymes while on the study drug.My pancreatic cancer is confirmed and can be surgically removed or has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Arm VI (AZD5305)
- Group 2: Arm VII (tremelimumab)
- Group 3: Arm II (cobimetinib)
- Group 4: Arm IV (onvansertib)
- Group 5: Arm I (olaparib)
- Group 6: Arm V (azenosertib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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