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Anti-metabolites

Onvansertib + Chemotherapy for Pancreatic Cancer

Phase 2

Waitlist Available

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

Histologically or cytologically-proven adenocarcinoma of the exocrine pancreas with locally advanced or metastatic disease

Must have at least one disease lesion that is amenable to biopsy procedures performed per institutional standards

Must not have

Prior treatment with a PLK1 inhibitor

Any concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after last dose of study intervention

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test how well a combination of onvansertib, gemcitabine, and nab-paclitaxel works in treating patients with advanced pancreatic cancer that cannot be removed by

Who is the study for?

This trial is for patients with advanced pancreatic ductal carcinoma that's spread and can't be surgically removed. It's not specified who can't join, but typically those with serious health issues or allergies to the drugs would be excluded.

What is being tested?

The study tests onvansertib combined with chemotherapy drugs gemcitabine and nab-paclitaxel in treating advanced pancreatic cancer. Onvansertib targets a protein called PLK1 to stop tumor growth, while the chemo aims to kill or halt cancer cell division.

What are the potential side effects?

Potential side effects include typical reactions to chemotherapy like nausea, fatigue, hair loss, increased risk of infection due to low blood counts, as well as any specific reactions related to onvansertib which are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of pancreatic cancer that has spread.

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I have a tumor that can be biopsied according to hospital rules.

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I am 18 years old or older.

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I am able to care for myself and perform daily activities.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a PLK1 inhibitor before.

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I do not have any severe or uncontrolled health conditions like diabetes or high blood pressure.

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I have not had major surgery in the last 6 weeks.

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I have risk factors for a specific heart rhythm issue or low potassium levels.

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I have a condition that affects my ability to swallow or absorb pills.

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I am not on any other cancer treatments or live vaccines while on the study medication.

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I am allergic to onvansertib, gemcitabine, nab-paclitaxel, or similar drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last dose of study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last dose of study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose of study intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Incidence of treatment-emergent adverse events (AEs) and serious AEs

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (onvansertib monotherapy lead-in, GnP)Experimental Treatment8 Interventions

Patients receive onvansertib PO QD on days 1-10. Patients then receive onvansertib, gemcitabine, and nab-paclitaxel as in Group 1. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo electrocardiography at baseline, as well as blood sample collection, tumor biopsy, CT, MRI, and/or PET throughout the trial.

Group II: Group 1 (onvansertib, GnP)Experimental Treatment8 Interventions

Patients receive onvansertib PO QD on days 1-5, 8-12, and 15-19 and gemcitabine IV and nab-paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo electrocardiography at baseline, as well as blood sample collection, tumor biopsy, CT, MRI, and/or PET throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160