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Pancreatic CancerPhase 1NCT02657330

Study of SBP-101 in Pancreatic Cancer

A Phase 1 study testing SBP-101 in people with Pancreatic Cancer and Ductal Adenocarcinoma of the Pancreas, run by Panbela Therapeutics, Inc. at 4 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 phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SBP-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
4 sitesin 2 countries
Study dates
Jan 2016to Oct 2017
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 locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included.
  • Measurable disease on CT or MRI scan by RECIST criteria (required for Phase 1b only).
  • ECOG Performance Status 0 or 1.
  • Received and failed, or were intolerant to, at least 1 prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma.
  • Adult, at least 18 years of age, 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.
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  • Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: Absolute neutrophil count ≥1.5 x 10^9/L, Hemoglobin ≥9.0 g/dL (90 g/L), Platelets ≥100 x 10^9/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, Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation
  • QTc interval ≤ 470 msec at Baseline
  • 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)
  • Glycosylated hemoglobin (Hgb A1C) > 8.0%
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  • Life expectancy <16 weeks
  • Presence of known active bacterial, fungal, or viral infection requiring systemic therapy
  • Known 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.
  • Known, existing coagulopathy or receiving anticoagulants
  • Pregnant or lactating
  • Major surgery within 4 weeks of the start of study treatment, without complete recovery
  • Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States2 sites

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

  • Mayo Clinic

    Scottsdale, Arizona, 85259-5499

Other trials in United States

Australia2 sites

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Ashford Cancer Centre

    Kurralta Park, South Australia, 5037

Other trials in Australia

About this study

Official title: A Phase 1A/1B Study of SBP-101 in Previously Treated Subjects With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.

Read the detailed description

This first-in-human study of SBP-101 will be conducted in two phases: dose escalation and expansion. The dose escalation phase of the study is to evaluate the safety, tolerability and PK profile of SBP-101 in subjects with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma. Up to 48 subjects may be enrolled in dose escalation. The expansion phase of the study will consist of 24 additional subjects who will receive the maximum tolerated dose of SBP-101 based on data from the dose escalation phase of the study.

Being tested
SBP-101
Keywords
Locally Advanced, Metastatic
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis

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]

    Subcutaneous drug, escalating dose cohorts

Study groups in NCT02657330
Study groupRoleWhat they receive
SBP-101ExperimentalSBP-101 is administered as a subcutaneous injection once daily, Monday through Friday for 3 weeks (total of 15 doses) followed by a 5-week rest period (3 weeks on, 5 weeks off = 1 treatment cycle). Dose escalation in phase 1a will continue until the maximum tolerated dose is determined.
Receives: Drug: SBP-101

What is being measured

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

  1. Maximum tolerated dose of SBP-101

    Measured: Up to 18 months following the first dose of treatment

Secondary outcomes (5)

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

    Measured: Up to 30 months following the first dose of treatment

  2. Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions

    Measured: Every 8 weeks during treatment assessed up to 30 months

  3. Area under the plasma concentration versus time curve (AUC)

    Measured: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

  4. Peak plasma concentration (Cmax)

    Measured: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

  5. Plasma drug half-life

    Measured: Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

Timeline

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

  1. First posted15 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionOct 2017
  4. Study completionOct 2017

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02657330
Sponsor's protocol ID
CL-SBP-101-01
Status last verified
Apr 2018
First submitted
22 Dec 2015
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBP-101 in people with Pancreatic Cancer and Ductal Adenocarcinoma of the Pancreas, run by Panbela Therapeutics, Inc. at 4 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 9 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 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Australia. 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?

Maximum tolerated dose of SBP-101 (time frame: Up to 18 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 NCT02657330.

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 20 Apr 2018.

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