Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02340117|
Recruitment Status : Recruiting
First Posted : January 16, 2015
Last Update Posted : February 8, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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 2022|
|Estimated Study Completion Date :||December 2023|
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with histologic or cytologic diagnosis of stage IV metastatic pancreatic adenocarcinoma.
- One or more tumors measurable on CT scan.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Life expectancy of at least 3 months.
- Age ≥ 18 years.
- Signed, written IRB-approved informed consent.
- A negative pregnancy test (if female and of child-bearing potential).
Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT), ALT (SGPT) ≤ 3.0 x ULN
- Serum creatinine ≤ 1.5 X ULN
Acceptable hematologic status:
- Absolute neutrophil count ≥ 1500 cells/mm³
- Platelet count ≥ 100,000 (plt/mm³)
- Hemoglobin ≥ 10 g/dL
Acceptable blood sugar control
*Fasting glucose value ≤ 160 mg/dL
- Urinalysis: No clinically significant abnormalities.
- PT and PTT ≤ 1.5 X ULN
- For men and women of child-producing potential, willingness to use of effective contraceptive methods during the study.
- NOT have received any prior cytotoxic chemotherapy or investigational therapy. However, this study may be used as 2nd line treatment of patients who progressed on or were intolerant of 1st line FOLFIRINOX for the primary or metastatic disease. Prior treatment with gemcitabine administered as radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- They also must NOT have received chemotherapy, radiotherapy, surgery or investigational therapy for the treatment of metastatic disease.
- Organ function characterized by ≤ Grade 1.
- Patient has received any prior cytotoxic chemotherapy for pancreatic cancer with the exception of patients who progressed on or were intolerant of 1st line FOLFIRINOX in primary or metastatic disease. Prior treatment with gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. Patients who previously had and were treated with standard therapy for non-pancreatic cancer will be evaluated for entry into the trial on a case-by-case basis.
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, unstable angina (chest pain greater than three times weekly while on therapy), evidence of ischemia on ECG, or abnormal stress echocardiogram with evidence of ischemia, or LVEF < 50%.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Treated with antibiotics for infection within one week prior to study entry.
- Fever (> 38.1°C)
- Have hematological malignancy
- Have diastolic blood pressure of > 90 mm Hg resting at baseline despite medication.
- Pregnant or nursing women.
- Treatment with surgery, or investigational therapy within 28 days prior to study entry or radiation therapy within 6 months prior to study entry.
- Have received chemotherapy, radiotherapy, surgery or investigational therapy for the treatment of metastatic disease.
- Unwillingness or inability to comply with procedures required in this protocol.
- Known infection with HIV, Hepatitis B, or Hepatitis C.
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- Patients who are currently receiving any other investigational agent.
- Patients who are currently taking Coumadin or Coumadin derivatives other than to maintain patency of venous access lines.
- Receiving systemic steroids or other chronic immunosuppressive medications within 30 days prior to study entry
- Receiving hematopoietic growth factors on a regular basis
Had within six months prior to enrollment any of the following:
- Cerebrovascular accident
- Uncontrolled congestive heart failure
- Have significant baseline neuropathies
- Requires renal dialysis
- Had prior exposure to gene vector delivery products
- Had previously experienced a severe hypersensitivity reaction to gemcitabine or nab-paclitaxel
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|
|Responsible Party:||SynerGene Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||January 16, 2015 Key Record Dates|
|Last Update Posted:||February 8, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action