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Study of SBP-101 in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02657330
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sun BioPharma Inc

Brief Summary:
This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Ductal Adenocarcinoma of the Pancreas Drug: SBP-101 Phase 1

Detailed Description:
This first-in-human study of SBP-101 will be conducted in two phases: dose escalation and expansion. The dose escalation phase of the study is to evaluate the safety, tolerability and PK profile of SBP-101 in subjects with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma. Up to 48 subjects may be enrolled in dose escalation. The expansion phase of the study will consist of 24 additional subjects who will receive the maximum tolerated dose of SBP-101 based on data from the dose escalation phase of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1A/1B Study of SBP-101 in Previously Treated Subjects With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Study Start Date : January 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: SBP-101
SBP-101 is administered as a subcutaneous injection once daily, Monday through Friday for 3 weeks (total of 15 doses) followed by a 5-week rest period (3 weeks on, 5 weeks off = 1 treatment cycle). Dose escalation in phase 1a will continue until the maximum tolerated dose is determined.
Drug: SBP-101
Subcutaneous drug, escalating dose cohorts
Other Names:
  • diethyl dihydroxyhomospermine
  • [(HO)2-DEHSPM]




Primary Outcome Measures :
  1. Maximum tolerated dose of SBP-101 [ Time Frame: Up to 18 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 30 months following the first dose of treatment ]
  2. Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions [ Time Frame: Every 8 weeks during treatment assessed up to 30 months ]
  3. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks) ]
  4. Peak plasma concentration (Cmax) [ Time Frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks) ]
  5. Plasma drug half-life [ Time Frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks) ]


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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 locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included.
  • Measurable disease on CT or MRI scan by RECIST criteria (required for Phase 1b only).
  • ECOG Performance Status 0 or 1.
  • Received and failed, or were intolerant to, at least 1 prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma.
  • Adult, at least 18 years of age, 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.
  • Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: Absolute neutrophil count ≥1.5 x 10^9/L, Hemoglobin ≥9.0 g/dL (90 g/L), Platelets ≥100 x 10^9/L, 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, Bilirubin ≤1.5 x ULN, Prothrombin time (PT) / international normalized ratio (INR) ≤1.5 x ULN, Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation
  • QTc interval ≤ 470 msec at Baseline
  • 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)
  • Glycosylated hemoglobin (Hgb A1C) > 8.0%
  • Life expectancy <16 weeks
  • Presence of known active bacterial, fungal, or viral infection requiring systemic therapy
  • Known 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.
  • Known, existing coagulopathy or receiving anticoagulants
  • Pregnant or lactating
  • Major surgery within 4 weeks of the start of study treatment, without complete recovery
  • Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug

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): NCT02657330


Locations
United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Mayo Clinic
Scottsdale, Arizona, United States, 85259-5499
Australia, South Australia
Ashford Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Sun BioPharma Inc
Investigators
Study Director: Suzanne Gagnon, MD Sun BioPharma Inc

Responsible Party: Sun BioPharma Inc
ClinicalTrials.gov Identifier: NCT02657330     History of Changes
Other Study ID Numbers: CL-SBP-101-01
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Sun BioPharma Inc:
Locally Advanced
Metastatic

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases