Trials / Withdrawn

WithdrawnNCT06398587

Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma

An Open-Label, Phase II Trial to Assess Efficacy and Safety of Onvansertib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated, Locally-Advanced or Unresectable Pancreatic Adenocarcinoma

Status: Withdrawn
Phase: Phase 2
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: OHSU Knight Cancer Institute · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well onvansertib in combination with gemcitabine and nab-paclitaxel works in treating patients with pancreatic ductal carcinoma (PDAC) that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable), or that has spread from where it first started (primary site) to other places in the body (metastatic). Onvansertib is a small chemical molecule that binds and stops the function of of PLK1 in tumor cells. By attacking the PLK1 protein, onvansertib is thought to reduce tumor cells ability to replicate and grow; causing them to die. Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with onvansertib may kill more tumor cells in patients with locally-advanced, unresectable, or metastatic pancreatic ductal carcinoma.

Detailed description

PRIMARY OBJECTIVE: I. To assess preliminary response to treatment with onvansertib and gemcitabine and nab-paclitaxel (GnP). SECONDARY OBJECTIVES: I. To assess the safety of onvansertib in combination with GnP. II. To assess the rate of disease control following treatment with onvansertib and GnP in patients with PDAC. III. To estimate the duration of response (DOR). IV. To estimate the time to disease progression. V. To estimate the progression-free survival associated with onvansertib and GnP. VI. To estimate the overall survival associated with onvansertib and GnP. EXPLORATORY OBJECTIVE: I. To evaluate therapy induced changes in the tumor and tumor ecosystem. OUTLINE: This is a safety lead-in study of onvansertib in combination with GnP, followed by a phase II study. Patients are assigned to 1 of 2 groups. GROUP 1: Patients receive onvansertib orally (PO) once daily (QD) on days 1-5, 8-12, and 15-19 and gemcitabine intravenously (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, computed tomography (CT), magnetic resonance imaging (MRI), and/or positron emission tomography (PET) throughout the trial. GROUP 2: 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. Upon completion of the study treatment, patients are followed up at 30 days and then every 3 months for up to 12 months from date of last dose of study drug.

Conditions

Interventions

Type	Name	Description
DRUG	Onvansertib	Given PO
DRUG	Gemcitabine	Given IV
DRUG	Nab-paclitaxel	Given IV
PROCEDURE	Electrocardiography	Undergo electrocardiography
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Positron Emission Tomography	Undergo PET
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Biospecimen Collection	Undergo tumor biopsy
PROCEDURE	Computed Tomography	Undergo CT

Timeline

Start date: 2024-08-01
Primary completion: 2026-05-04
Completion: 2027-06-07
First posted: 2024-05-03
Last updated: 2024-07-19

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06398587. Inclusion in this directory is not an endorsement.