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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03412799




Registration number
NCT03412799
Ethics application status
Date submitted
19/01/2018
Date registered
25/01/2018
Date last updated
29/06/2018

Titles & IDs
Public title
Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
Scientific 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
Secondary ID [1] 0 0
CL-SBP-101-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer Metastatic 0 0
Pancreatic Cancer Stage IV 0 0
Stage IV Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SBP-101
Treatment: Drugs - nab-paclitaxel
Treatment: Drugs - Gemcitabine Injection

Treatment: Drugs: SBP-101
Administered as subcutaneous (SC) injection, escalating dose cohorts

Treatment: Drugs: nab-paclitaxel
Administered as intravenous (IV) infusion

Treatment: Drugs: Gemcitabine Injection
Administered as intravenous (IV) infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended dose of SBP-101
Timepoint [1] 0 0
Up to 12 months following the first dose of treatment
Secondary outcome [1] 0 0
Number of subjects with adverse events as a measure of safety and tolerability
Timepoint [1] 0 0
Up to 24 months following the first dose of treatment
Secondary outcome [2] 0 0
Tumor response will be evaluated on RECIST definitions
Timepoint [2] 0 0
Every 8 weeks during treatment assessed up to 24 months
Secondary outcome [3] 0 0
Area under the plasma concentration versus time curve (AUC) for all three drugs
Timepoint [3] 0 0
Day 1 of Cycle 1
Secondary outcome [4] 0 0
Peak plasma concentration (Cmax) for all three drugs
Timepoint [4] 0 0
Day 1 of Cycle 1

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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%

- 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

- Concomitant use of drugs or supplements known to influence the expression and function
of CYP3A4 and/or CYP2C8

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Blacktown Cancer & Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sun BioPharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03412799
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suzanne Gagnon, MD
Address 0 0
Sun BioPharma Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sheri Smith
Address 0 0
Country 0 0
Phone 0 0
952-908-9986
Fax 0 0
Email 0 0
ssmith@couranteoncology.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable