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Pancreatic Cancer MetastaticPhase 1NCT03412799

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

A Phase 1 study testing SBP-101, nab-paclitaxel and Gemcitabine Injection in people with Pancreatic Cancer Metastatic and Pancreatic Cancer Stage IV, run by Panbela Therapeutics, Inc. at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SBP-101, nab-paclitaxel and Gemcitabine Injection
Type of treatment
Injection or infusion
How many people
50 participants
Where
7 sitesin 2 countries
Study dates
4 Jun 2018to 28 Feb 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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.)

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Australia4 sites

  • Blacktown Cancer & Haematology Centre

    Blacktown, New South Wales, 2148

  • Austin Health

    Heidelberg, Victoria, 3084

  • Ashford Cancer Centre

    Kurralta Park, South Australia, 5037

  • John Flynn Private Hospital

    Tugun, Queensland, 4224

Other trials in Australia

United States3 sites

  • University of Florida

    Gainesville, Florida, 32610

  • Scripps MD Anderson Cancer Center

    La Jolla, California, 92037

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
SBP-101, nab-paclitaxel, Gemcitabine Injection
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBP-101Drug

    Also called diethyl dihydroxyhomospermine, [(HO)2-DEHSPM]

    Administered as subcutaneous (SC) injection, escalating dose cohorts

  • nab-paclitaxelDrug

    Also called abraxane, protein-bound paclitaxel

    Administered as intravenous (IV) infusion

  • Gemcitabine InjectionDrug

    Also called gemcitabine hydrochloride, Gemzar

    Administered as intravenous (IV) infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended dose of SBP-101

    Measured: Up to 12 months following the first dose of treatment

Secondary outcomes (4)

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

    Measured: Up to 24 months following the first dose of treatment

  2. Tumor response will be evaluated on RECIST definitions

    Measured: Every 8 weeks during treatment assessed up to 24 months

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

    Measured: Day 1 of Cycle 1

  4. Peak plasma concentration (Cmax) for all three drugs

    Measured: Day 1 of Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start4 Jun 2018
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412799
Sponsor's protocol ID
CL-SBP-101-03
Status last verified
May 2022
First submitted
19 Jan 2018
Last updated
25 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBP-101, nab-paclitaxel and Gemcitabine Injection in people with Pancreatic Cancer Metastatic and Pancreatic Cancer Stage IV, run by Panbela Therapeutics, Inc. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended dose of SBP-101 (time frame: Up to 12 months following the first dose of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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