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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

Study Summary

This trial is exploring how four different drugs work in patients with pancreatic cancer.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of all pharmacodynamic feasibility-evaluable participants within a study arm that have a measurable change in post-treatment tumor biology from baseline
Secondary outcome measures
Incidence of >= grade 3 toxicities for each assigned window treatment (as described in sub-protocol)

Trial Design

4Treatment groups
Experimental Treatment
Group I: 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 II: 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 III: 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.
Group IV: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
2017
Completed Phase 2
~220
Cobimetinib
2017
Completed Phase 3
~2660
Olaparib
2007
Completed Phase 4
~2140

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
230 Previous Clinical Trials
2,090,646 Total Patients Enrolled

Media Library

Cobimetinib (MEK/ERK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04005690 — Phase < 1
Pancreatic Cancer Research Study Groups: Arm II (cobimetinib), Arm IV (onvansertib), Arm I (olaparib), Arm V (azenosertib)
Pancreatic Cancer Clinical Trial 2023: Cobimetinib Highlights & Side Effects. Trial Name: NCT04005690 — Phase < 1
Cobimetinib (MEK/ERK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04005690 — Phase < 1

Frequently Asked Questions

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

Are there still available slots in this clinical research endeavor?

"That's correct. The details published on clinicaltrials.gov confirm that this investigation is currently enrolling participants, having been posted in August 2019 and last updated in October 2022. 80 patients will be required to join from a single site."

Answered by AI

Is eligibility for this trial confined to those under 40 or are older individuals accepted as well?

"This trial is suitable for individuals aged between 18 to 78. Conversely, 33 trials are available for minors and 1481 options are offered for seniors."

Answered by AI

What other investigations have transpired concerning Cobimetinib?

"Currently, there are 235 active trials for cobimetinib with 30 of those in phase 3. These studies span 10365 locations across the globe and a particularly high concentration can be found around Houston, Texas."

Answered by AI

What is the upper limit to participant recruitment for this trial?

"Affirmative. The information on clinicaltrials.gov states that this experiment is actively seeking volunteers, with an initial post date of August 1st 2019 and most recent update occurring October 31st 2022. 80 enrollees are needed from a single location."

Answered by AI

Am I eligible to join this clinical investigation?

"This medical trial has 80 enrollees, aged between 18 and 78 who have been diagnosed with stage iib pancreatic cancer ajcc v8. Furthermore, applicants need to be either treatment-naïve or have completed prior therapy for PDAC (Pancreatic Ductal Adenocarcinoma) at least ten days ago. Imaging must show one lesion that can be biopsied according to institutional standards; though this criterion may be waived depending on individual circumstances. Lastly, the Eastern Cooperative Oncology Group's performance rating of 0-2 is mandatory."

Answered by AI

Has this type of research previously been conducted?

"Currently, there are 235 independent clinical trials actively investigating cobimitinib spanning 61 nations and 1524 cities. The initial experiment was run in 2005 by AstraZeneca with 98 patients taking part and has since been followed up by 94 separate studies. It achieved stage 1 of the drug approval process that year."

Answered by AI

What medical conditions does Cobimetinib typically ameliorate?

"Cobimetinib is frequently prescribed for advaced medical directives. It can also provide relief from malignant neoplasm of ovary, primary peritoneal cancer, hallucinations, and somatic conditions."

Answered by AI
~24 spots leftby Jun 2026