Clinical Trials /

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

NCT03412799

Description:

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.

Related Conditions:
  • Pancreatic Acinar Cell Carcinoma
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: CL-SBP-101-03
  • NCT ID: NCT03412799

Conditions

  • Pancreatic Cancer Metastatic
  • Pancreatic Cancer Stage IV
  • Stage IV Pancreatic Cancer

Interventions

DrugSynonymsArms
SBP-101diethyl dihydroxyhomospermine, [(HO)2-DEHSPM]
nab-paclitaxelabraxane, protein-bound paclitaxel
Gemcitabine Injectiongemcitabine hydrochloride, Gemzar

Purpose

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.

Detailed Description

      The study will be conducted in two phases: dose escalation and expansion. Up to three dose
      levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion
      phase of the study will consist of 10 additional subjects who will receive the recommended
      dose of SBP-101 combined with nab-paclitaxel and gemcitabine.
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        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.

        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)

          -  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

          -  Subjects taking metformin. Diabetics on treatment with metformin, or any other
             derivative thereof, must discontinue it while on study. (Other diabetic medications
             are allowed.)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recommended dose of SBP-101
Time Frame:Up to 12 months following the first dose of treatment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of subjects with adverse events as a measure of safety and tolerability
Time Frame:Up to 24 months following the first dose of treatment
Safety Issue:
Description:
Measure:Tumor response will be evaluated on RECIST definitions
Time Frame:Every 8 weeks during treatment assessed up to 24 months
Safety Issue:
Description:
Measure:Area under the plasma concentration versus time curve (AUC) for all three drugs
Time Frame:Day 1 of Cycle 1
Safety Issue:
Description:
Measure:Peak plasma concentration (Cmax) for all three drugs
Time Frame:Day 1 of Cycle 1
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sun BioPharma Inc

Last Updated

September 9, 2020