Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03412799 |
Recruitment Status :
Active, not recruiting
First Posted : January 26, 2018
Last Update Posted : January 12, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer Metastatic Pancreatic Cancer Stage IV Stage IV Pancreatic Cancer | Drug: SBP-101 Drug: nab-paclitaxel Drug: Gemcitabine Injection | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 4, 2018 |
Estimated Primary Completion Date : | February 28, 2022 |
Estimated Study Completion Date : | February 28, 2022 |

- Drug: SBP-101
Administered as subcutaneous (SC) injection, escalating dose cohortsOther Names:
- diethyl dihydroxyhomospermine
- [(HO)2-DEHSPM]
- Drug: nab-paclitaxel
Administered as intravenous (IV) infusionOther Names:
- abraxane
- protein-bound paclitaxel
- Drug: Gemcitabine Injection
Administered as intravenous (IV) infusionOther Names:
- gemcitabine hydrochloride
- Gemzar
- Recommended dose of SBP-101 [ Time Frame: Up to 12 months following the first dose of treatment ]
- 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 ]
- Tumor response will be evaluated on RECIST definitions [ Time Frame: Every 8 weeks during treatment assessed up to 24 months ]
- Area under the plasma concentration versus time curve (AUC) for all three drugs [ Time Frame: Day 1 of Cycle 1 ]
- Peak plasma concentration (Cmax) for all three drugs [ Time Frame: Day 1 of Cycle 1 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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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.
- 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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412799
United States, California | |
Scripps MD Anderson Cancer Center | |
La Jolla, California, United States, 92037 | |
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 | |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Australia, New South Wales | |
Blacktown Cancer & Haematology Centre | |
Blacktown, New South Wales, Australia, 2148 | |
Australia, Queensland | |
John Flynn Private Hospital | |
Tugun, Queensland, Australia, 4224 | |
Australia, South Australia | |
Ashford Cancer Centre | |
Kurralta Park, South Australia, Australia, 5037 | |
Australia, Victoria | |
Austin Health | |
Heidelberg, Victoria, Australia, 3084 |
Study Director: | Suzanne Gagnon, MD | Panbela Therapeutics, Inc. |
Responsible Party: | Panbela Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03412799 |
Other Study ID Numbers: |
CL-SBP-101-03 |
First Posted: | January 26, 2018 Key Record Dates |
Last Update Posted: | January 12, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |