Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer

NCT02340117 | Active Not Recruiting Phase 2

• 1 other identifier: SGT53-02-1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is an open label Phase II study of the combination of intravenously administered SGT-53 and gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. The objective of the study is to evaluate the safety, tolerability, toxicity and efficacy (specifically Progression Free Survival at 5.5 month (PFS5.5mos)) of this combination therapy.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS) at 5.5 months

  PFS5.5mos will be assessed by objective radiographic assessment

  5.5 months

• Objective response rate (ORR)

  ORR will be assessed by objective radiographic assessment using RECIST 1.1 criteria

  Up to 5 years

Secondary Outcomes (6)

• Progression free survival (PFS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Time to disease progression (TTP)

  Up to 5 years

• Disease control rate (DCR)

  16 weeks

• Duration of disease control

  Up to 5 years

Study Arms (1)

SGT-53 with gemcitabine/nab-paclitaxel

EXPERIMENTAL

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.

Genetic: SGT-53; Drug: nab-paclitaxel; Drug: Gemcitabine

Interventions

SGT-53 GENETIC

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.

SGT-53 with gemcitabine/nab-paclitaxel

nab-paclitaxel DRUG

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.

Also known as: Abraxane ABI-007, Albumin-bound paclitaxel

SGT-53 with gemcitabine/nab-paclitaxel

Gemcitabine DRUG

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.

Also known as: Gemzar

SGT-53 with gemcitabine/nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SynerGene Therapeutics, Inc.: lead

Study Sites (1)

Mary Crowley Cancer Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Minal Barve, MD

  Mary Crowley Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 16, 2015
• Study Start: January 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1)