Study Of SBP-101 Combined With Nab-Paclitaxel And Gemcitabine In Pancreatic Cancer

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 Plan

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

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-01-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-05-23
First Submitted that Met QC Criteria 2018-01-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-05-25
First Posted (ACTUAL) 2018-01-26	Results First Posted N/A	Last Verified 2022-05

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Recommended dose of SBP-101		Up to 12 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 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

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 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:

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.

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.)

Collaborators and Investigators

Publications

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

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Resources

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Caregivers

Clinical Trial Record