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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02657330




Registration number
NCT02657330
Ethics application status
Date submitted
22/12/2015
Date registered
15/01/2016
Date last updated
20/04/2018

Titles & IDs
Public title
Study of SBP-101 in Pancreatic Cancer
Scientific title
A Phase 1A/1B Study of SBP-101 in Previously Treated Subjects With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Secondary ID [1] 0 0
CL-SBP-101-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Ductal Adenocarcinoma of the Pancreas 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

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.


Treatment: Drugs: SBP-101
Subcutaneous drug, escalating dose cohorts
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum tolerated dose of SBP-101
Timepoint [1] 0 0
Up to 18 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 30 months following the first dose of treatment
Secondary outcome [2] 0 0
Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions
Timepoint [2] 0 0
Every 8 weeks during treatment assessed up to 30 months
Secondary outcome [3] 0 0
Area under the plasma concentration versus time curve (AUC)
Timepoint [3] 0 0
Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Secondary outcome [4] 0 0
Peak plasma concentration (Cmax)
Timepoint [4] 0 0
Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Secondary outcome [5] 0 0
Plasma drug half-life
Timepoint [5] 0 0
Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
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%
* 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Panbela Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02657330
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suzanne Gagnon, MD
Address 0 0
Panbela Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02657330