- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657330
Study of SBP-101 in Pancreatic Cancer
April 18, 2018 updated by: Panbela Therapeutics, Inc.
A Phase 1A/1B Study of SBP-101 in Previously Treated Subjects With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
29
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Ashford Cancer Centre
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital
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Arizona
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Scottsdale, Arizona, United States, 85258
- HonorHealth Research Institute
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Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Subcutaneous drug, escalating dose cohorts
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Maximum tolerated dose of SBP-101
Time Frame: Up to 18 months following the first dose of treatment
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Up to 18 months following the first dose of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Up to 30 months following the first dose of treatment
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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
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Every 8 weeks during treatment assessed up to 30 months
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Area under the plasma concentration versus time curve (AUC)
Time Frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
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Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
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Peak plasma concentration (Cmax)
Time Frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
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Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
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Plasma drug half-life
Time Frame: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
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Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Suzanne Gagnon, MD, Panbela Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
December 22, 2015
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 15, 2016
Study Record Updates
Last Update Posted (Actual)
April 20, 2018
Last Update Submitted That Met QC Criteria
April 18, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-SBP-101-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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