Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02340117|
Recruitment Status : Recruiting
First Posted : January 16, 2015
Last Update Posted : February 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Genetic: SGT-53 Drug: nab-paclitaxel Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Combined Targeted p53 Gene Therapy (SGT-53) Plus Gemcitabine/Nab-Paclitaxel for Treatment of Metastatic Pancreatic Cancer|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: SGT-53 with gemcitabine/nab-paclitaxel
A course of therapy will include 7 weeks of treatment. SGT-53, at 3.6 mg DNA/infusion, will be administered bi-weekly on days 1 and 5 in weeks 1-3, weekly on day 3 in week 4, and weekly on day 1 in weeks 5-7. Patients who are responding to treatment may receive two additional courses (7 weeks) of SGT-53/gemcitabine/nab-paclitaxel therapy at investigator discretion. If still responding to treatment, they may continue on SGT-53/gemcitabine/nab-paclitaxel at investigator discretion with the approval of the sponsor.
The dose of SGT-53 will be 3.6 mg DNA/infusion. If necessary, the dose of SGT-53 can be de-escalated to 2.4 mg, 1.2 mg or 0.6 mg DNA per infusion in the event that increased toxicity probably or definitely related to SGT-53 is observed with the combination.
The dose of nab-paclitaxel will be 125 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7. If increased toxicities related to administration of nab-paclitaxel is observed, the dose of nab-paclitaxel can be reduced to 100 or 75 mg/m² when appropriate.
The dose of gemcitabine will be 1000 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7, after the administration of nab-paclitaxel. If increased toxicities related to administration of gemcitabine is observed, the dose of gemcitabine can be reduced to 800 or 600 mg/m² when appropriate.
Other Name: Gemzar
- Progression free survival (PFS) at 5.5 months [ Time Frame: 5.5 months ]PFS5.5mos will be assessed by objective radiographic assessment
- Objective response rate (ORR) [ Time Frame: Up to 5 years ]ORR will be assessed by objective radiographic assessment using RECIST 1.1 criteria
- Progression free survival (PFS) [ Time Frame: Up to 5 years ]Progression free survival (PFS) will be defined as the time from registration until confirmed tumor progression or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: Up to 5 years ]Survival will be defined as the time from the date of registration to the date of death (any cause).
- Time to disease progression (TTP) [ Time Frame: Up to 5 years ]Time to disease progression is defined as the time from registration until confirmed tumor progression, but not including deaths.
- Disease control rate (DCR) [ Time Frame: 16 weeks ]Disease control rate (SD for ≥16 weeks plus CR and PR) will be analyzed using Kaplan-Meier methods.
- Duration of disease control [ Time Frame: Up to 5 years ]Disease control duration is measured from the time of registration until documented confirmed tumor progression.
- Adverse events [ Time Frame: Study drug initiation through 30 days after the last dose of study drug or end of treatment, whichever is later. ]Safety will be evaluated by the incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), physical examination, laboratory abnormalities during study drug dosing and percentage of patients experiencing dose modifications, interruptions, and/or discontinuation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340117
|Contact: Referral Officefirstname.lastname@example.org|
|United States, Texas|
|Mary Crowley Cancer Research Center||Recruiting|
|Dallas, Texas, United States, 75201|
|Contact: Alyssa Roth 972-566-3061 email@example.com|
|Principal Investigator:||Minal Barve, MD||Mary Crowley Cancer Research Center|