Study Of SBP-101 In Pancreatic Cancer

Study Overview

Study of SBP-101 in Pancreatic Cancer

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.

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.

Pancreatic Cancer
Ductal Adenocarcinoma of the Pancreas

DRUG: SBP-101

CL-SBP-101-01

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-12-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-04-18
First Submitted that Met QC Criteria 2016-01-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-04-20
First Posted (ACTUAL) 2016-01-15	Results First Posted N/A	Last Verified 2018-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 maxim	DRUG: SBP-101 Subcutaneous drug, escalating dose cohorts

Participant Group/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 maxim

DRUG: SBP-101

Subcutaneous drug, escalating dose cohorts

Primary Outcome Measures	Measure Description	Time Frame
Maximum tolerated dose of SBP-101		Up to 18 months following the first dose of treatment

Secondary Outcome Measures	Measure Description	Time Frame
Number of subjects with adverse events as a measure of safety and tolerability		Up to 30 months following the first dose of treatment
Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions		Every 8 weeks during treatment assessed up to 30 months
Area under the plasma concentration versus time curve (AUC)		Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Peak plasma concentration (Cmax)		Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Plasma drug half-life		Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Suzanne Gagnon, MD, Panbela Therapeutics, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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