Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398587
Status:
WITHDRAWN
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor withdrawal
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 andor 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
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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STUDY00026545 | OTHER | OHSU Knight Cancer Institute | None |
| NCI-2024-02588 | REGISTRY | None | None |