Study of SBP-101 in Pancreatic Cancer

NCT02657330 | Completed Phase 1 DMC

• 1 other identifier: CL-SBP-101-01
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 4

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.

Conditions

Pancreatic Cancer; Ductal Adenocarcinoma of the Pancreas

Keywords

Locally Advanced; Metastatic

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of SBP-101

  Up to 18 months following the first dose of treatment

Secondary Outcomes (5)

• 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)

Study Arms (1)

SBP-101

EXPERIMENTAL

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

Interventions

SBP-101 DRUG

Subcutaneous drug, escalating dose cohorts

Also known as: diethyl dihydroxyhomospermine, [(HO)2-DEHSPM]

SBP-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panbela Therapeutics, Inc.: lead

Study Sites (4)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259-5499, United States

Location

Ashford Cancer Centre

Kurralta Park, South Australia, 5037, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne Gagnon, MD

  Panbela Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 15, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

AU (2); US (2)