Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

NCT03412799 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CL-SBP-101-03
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 7

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.

Conditions

Pancreatic Cancer Metastatic; Pancreatic Cancer Stage IV; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Recommended dose of SBP-101

  Up to 12 months following the first dose of treatment

Secondary Outcomes (4)

• Number of subjects with adverse events as a measure of safety and tolerability

  Up to 24 months following the first dose of treatment

• Tumor response will be evaluated on RECIST definitions

  Every 8 weeks during treatment assessed up to 24 months

• Area under the plasma concentration versus time curve (AUC) for all three drugs

  Day 1 of Cycle 1

• Peak plasma concentration (Cmax) for all three drugs

  Day 1 of Cycle 1

Interventions

SBP-101 DRUG

Administered as subcutaneous (SC) injection, escalating dose cohorts

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

nab-paclitaxel DRUG

Administered as intravenous (IV) infusion

Also known as: abraxane, protein-bound paclitaxel

Gemcitabine Injection DRUG

Administered as intravenous (IV) infusion

Also known as: gemcitabine hydrochloride, Gemzar

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 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:
• Absolute neutrophil count ≥1.5 x 109/L
• Hemoglobin ≥9.0 g/dL (90 g/L)
• Platelets ≥100 x 109/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 if not on anti-coagulants
• Calculated creatinine clearance \>50 mL/min using the Cockcroft and Gault equation
• QTc interval ≤ 470 msec at Baseline.

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)
• 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
• 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

Sponsors & Collaborators

• Panbela Therapeutics, Inc.: lead

Study Sites (7)

Scripps MD Anderson Cancer Center

La Jolla, California, 92037, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Blacktown Cancer & Haematology Centre

Blacktown, New South Wales, 2148, Australia

Location

John Flynn Private Hospital

Tugun, Queensland, 4224, Australia

Location

Ashford Cancer Centre

Kurralta Park, South Australia, 5037, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

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: January 19, 2018
• First Posted: January 26, 2018
• Study Start: June 4, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

AU (4); US (3)