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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06115499
Other study ID # A022106
Secondary ID NCI-2023-06547
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date December 6, 2023
Est. completion date December 9, 2029

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact Jamie Crawley, MA
Phone 773-702-9934
Email jcrawley@bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.


Description:

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Study Design


Intervention

Drug:
Nab paclitaxel
Given IV
Gemcitabine
Given IV
Cisplatin
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo MRI
Computed Tomography
Undergo CT
Biospecimen Collection
Undergo blood sample collection

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Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate (ORR) (Phase II) Will be assessed by the proportion of patients who achieve complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) during the protocol treatment. Fisher's exact test will be conducted based on the first 32 patients in each arm who meet PP population criteria. Up to 12 months
Primary Overall Survival (OS) (Phase III) Will be conducted on modified intention-to-treat population. Stratified Cox model will be constructed to compare OS in the experimental arm to OS in the control arm. From the date of randomization to the date of death due to all causes, assessed up to 5 years
Secondary Progression-free survival Will be assessed per RECIST 1.1. Will be estimated, in each arm, using the method of Kaplan-Meier and compared by stratified Cox regression model. From the date of randomization to the date of first documented disease progression or death due to all causes, whichever occurs first, assessed up to 5 years
Secondary Incidence of adverse events The maximum grade for each type of adverse events that are possibly, probably, or definitely related to study treatments will be recorded for each patient. Up to 30 days after the last dose of study treatment
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