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Trial record 2 of 2 for:    sbp-101

Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03412799
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun BioPharma Inc

Brief Summary:
This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Metastatic Pancreatic Cancer Stage IV Stage IV Pancreatic Cancer Drug: SBP-101 Drug: nab-paclitaxel Drug: Gemcitabine Injection Phase 1

Detailed Description:
The study will be conducted in two phases: dose escalation and expansion. Up to three dose levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion phase of the study will consist of 10 additional subjects who will receive the recommended dose of SBP-101 combined with nab-paclitaxel and gemcitabine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020



Intervention Details:
  • Drug: SBP-101
    Administered as subcutaneous (SC) injection, escalating dose cohorts
    Other Names:
    • diethyl dihydroxyhomospermine
    • [(HO)2-DEHSPM]
  • Drug: nab-paclitaxel
    Administered as intravenous (IV) infusion
    Other Names:
    • abraxane
    • protein-bound paclitaxel
  • Drug: Gemcitabine Injection
    Administered as intravenous (IV) infusion
    Other Names:
    • gemcitabine hydrochloride
    • Gemzar


Primary Outcome Measures :
  1. Recommended dose of SBP-101 [ Time Frame: Up to 12 months following the first dose of treatment ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Up to 24 months following the first dose of treatment ]
  2. Tumor response will be evaluated on RECIST definitions [ Time Frame: Every 8 weeks during treatment assessed up to 24 months ]
  3. Area under the plasma concentration versus time curve (AUC) for all three drugs [ Time Frame: Day 1 of Cycle 1 ]
  4. Peak plasma concentration (Cmax) for all three drugs [ Time Frame: Day 1 of Cycle 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. Patients with pancreatic acinar cell carcinoma may also be included.
  • Is previously untreated for metastatic pancreatic ductal adenocarcinoma, was diagnosed within the past 3 months, and is expected to receive standard treatment with gemcitabine and nab-paclitaxel.
  • Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.
  • ECOG Performance Status 0 or 1.
  • Adult, age ≥ 18 years, male or female.
  • Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study. Female subjects will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).
  • Adequate bone marrow, hepatic, renal and coagulation function as defined by the following:

    1. Absolute neutrophil count ≥1.5 x 109/L
    2. Hemoglobin ≥9.0 g/dL (90 g/L)
    3. Platelets ≥100 x 109/L
    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT ≤5 x ULN.
    5. Bilirubin ≤1.5 x ULN
    6. Prothrombin time (PT) / international normalized ratio (INR) ≤1.5 x ULN if not on anti-coagulants
    7. Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation
  • QTc interval ≤ 470 msec at Baseline.
  • Life expectancy ≥ 3 months.
  • Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement.

Exclusion Criteria:

  • Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
  • Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance
  • Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma
  • Have symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
  • Serum albumin <30 g/L (3.0 g/dL)
  • Evidence of deep vein thrombosis or pulmonary embolism or other thromboembolic event during screening
  • Presence of known active bacterial, fungal, or viral infection requiring systemic therapy
  • Known active infection with human immunodeficiency virus (HIV), hepatitis B or C
  • Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction
  • Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
  • Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.
  • Pregnant or lactating
  • Major surgery within 4 weeks of the start of study treatment, without complete recovery
  • Known hypersensitivity to any component of study treatments
  • Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug
  • Subjects taking metformin. Diabetics on treatment with metformin, or any other derivative thereof, must discontinue it while on study. (Other diabetic medications are allowed.)

Information from the National Library of Medicine

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): NCT03412799


Contacts
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Contact: Sheri Smith 952-908-9986 ssmith@couranteoncology.com
Contact: Tammy Groene 952-479-1196 tgroene@sunbiopharma.com

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Meg McEwan Veal    352-265-0680 ext 87656    mamcewan@ufl.edu   
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Chris LeFeber    585-275-0407    chris_lefeber@URMC.Rochester.edu   
Australia, New South Wales
Blacktown Cancer & Haematology Centre Recruiting
Blacktown, New South Wales, Australia, 2148
Contact: Raymond Tangunan    +61298818421    raymond.tanguanan@health.nsw.gov.au   
Australia, Queensland
John Flynn Private Hospital Recruiting
Tugun, Queensland, Australia, 4224
Contact: Sumit Lumba, MBBS, FRACP    +61 7 5506 7374    sumitlumba@me.com   
Australia, South Australia
Ashford Cancer Centre Recruiting
Kurralta Park, South Australia, Australia, 5037
Contact    +61 8 8292 2240      
Australia, Victoria
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Niall Tebutt, MBBS, FRACP    +61 3 9496 5000    niall.tebutt@onjcri.org.au   
Contact: Catherine Johnston    +61 9496 3038    catherine.johnston@austin.org.au   
Sponsors and Collaborators
Sun BioPharma Inc
Investigators
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Study Director: Suzanne Gagnon, MD Sun BioPharma Inc

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Responsible Party: Sun BioPharma Inc
ClinicalTrials.gov Identifier: NCT03412799     History of Changes
Other Study ID Numbers: CL-SBP-101-03
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs