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Metastatic Pancreatic AdenocarcinomaPhase 1/2PANTAX-IbNCT04652206

Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.

A Phase 1/2 study testing SCO-101, Gemcitabine and Nab paclitaxel in people with Metastatic Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, run by Scandion Oncology A/S at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel. The primary objectives are to establish the safety profile and the MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SCO-101, Gemcitabine and Nab paclitaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesin 2 countries
Study dates
27 Oct 2020to 15 May 2022
Phase
Phase 1/2
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

  • Patients are required to meet all of the following criteria for enrollment into the study:
  • Ability to understand and willingness to provide written informed consent before any trial-related activities.
  • Age 18 years or older.
  • Histologically or cytologically verified pancreatic adenocarcinoma.
  • Inoperable localized, locally advanced or metastatic pancreatic cancer, not amenable for curatively intended treatment, in patients who are to be treated with gemcitabine and nab-paclitaxel.
  • Measurable or non-measurable disease determined by CT scan or MRI, according to RECIST 1.1.
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  • Performance status of ECOG ≤ 2 and expected to tolerate the standard recommended (100%) gemcitabine and nab-paclitaxel dose.
  • Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy or treatment with cytotoxic or biologic agents.
  • ≥ 2 weeks must have elapsed since any prior surgery or radiotherapy.
  • Adequate conditions as evidenced by the following clinical laboratory values:
  • Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
  • Haemoglobin ≥ 6.0 mmol/L
  • Platelets ≥ 100 x 109 /L
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN and aspartate aminotransferase (AST) ≤ 2.5 x ULN*
  • Total Serum bilirubin ≤ 1.0 ULN
  • Alkaline phosphatase ≤ 2.5 x ULN*
  • Creatinine ≤ 1.5 ULN
  • eGFR within normal limits
  • Adequate blood clothing function as defined by the International Normalized Ratio (INR) ≤ 1.2
  • Life expectancy longer than 3 months.
  • Sexually active males and females of child-producing potential must use highly effective contraception (intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)) for the study duration and at least 6 months after the last dose of study drug.
  • Signed informed consent. *AST is not mandatory. In case of known liver metastases with ALT and AST ≤ 5 x ULN and/or alkaline phosphatase ≤ 5 x ULN: Patients who do not conform to the transaminase and/or alkaline phosphatase inclusion criteria, but who by the PI are considered in good PS and otherwise eligible for inclusion, and where the transaminase and/or alkaline phosphatase levels are considered elevated due to other reasons than deteriorated lever capacity, may be considered for inclusion based on conferred agreement between PI and sponsor.

Who cannot join

  • Patients meeting any of the following criteria will be excluded from enrollment:
  • Concurrent chemotherapy, radiotherapy, or other investigational drug during study period.
  • Previous surgeries with resection of the complete stomach or greater part of small intestines (excluding the duodenum), whereby absorption of SCO-101 may be affected. Treatment with Creon or similar is allowed.
  • Difficulty in swallowing tablets.
  • CNS metastases requiring steroids.
  • Treatment with antibiotics for infections or with clinical symptoms of active infection. Patients showing symptoms of CoViD19 must be tested for active CoViD19 infection.
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  • Known HIV positivity.
  • Known active hepatitis B or C.
  • Clinically significant (i.e. active) cardiovascular disease:
  • Stroke, Transient ischemic attack (TIA) or myocardial infarction within ≤ 6 months prior to day 1.
  • Unstable angina or NYHA Grade II or greater congestive heart failure (CHF).
  • Serious cardiac arrhythmia requiring medication.
  • Mental status, symptomatic epilepsy or other CNS disease where the investigator assesses the patient not fit for the clinical study.
  • Other medications or conditions that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results. Other severe medical conditions, including serious heart disease, unstable diabetes, uncontrolled hypercalcemia or previous organ transplants. Participation in another clinical trial with experimental medication within 30 days prior to registration.
  • Known hypersensitivity to gemcitabine and/or nab-paclitaxel.
  • Pregnant women or women who are breastfeeding.
  • Prior or present neuropathy > grade I (NCI-CTCAE v.5.0).
  • Curatively intended treatment.

Trial locations and contacts

4 sites in 2 countries.

Peter M Vestlev, MD contact

+4522779696

pmv@scandiononcology.com

4 sites in 2 countries

Denmark2 sites, 2 recruiting

  • Aalborg University Hospital

    Aalborg, 9000

    Morten Ladekarl, Prof., DMSc, morten.ladekarl@rn.dk

    Morten Ladekarl, Prof., DMSc

    Recruiting

  • Odense Universitetshospital

    Odense

    Per Pfeiffer, MD, per.pfeiffer@rsyd.dk

    Per Pfeiffer, MD

    Recruiting

Other trials in Denmark

Germany2 sites, 2 recruiting

  • Catholic Hospital Bochum - St. Josef-Hospital

    Bochum

    Anke Reinacher-Schick, MD, anke.reinacher@rub.de

    Anke Reinacher-Schick, MD

    Recruiting

  • University Hospital Of Ulm

    Ulm

    Thomas Ettrich, MD, thomas.ettrich@uniklinik-ulm.de

    Thomas Ettrich, MD

    Recruiting

Other trials in Germany

About this study

Official title: An Open-label Phase Ib Prospective Clinical Trial to Investigate Safety, Tolerability and Maximum Tolerated Dose for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.

An open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel. The primary objectives are to establish the safety profile and the MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel. The starting dose of SCO-101 is 150 mg and the dose may be increased to a maximum of 350 mg.

Read the detailed description

The study is an open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel. The primary objective is to establish the safety, tolerability and MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel. Secondary objectives are efficacy and to establish PK parameters of SCO-101. The target indication is patients with inoperal pancreatic cancer who are to be treated with gemcitabine and nab-paclitaxel. The study is designed as a standard 3+3 dose escalation study with increasing doses of SCO-101 and a fixed dose (standard regimen) of gemcitabine and nab-paclitaxel. An interim report will be prepared once the last patient in the MTD cohort has completed one treatment cycle. Patients will continue treatment until disease progression to evaluate secondary objectives. One treatment Cycle is 28 days. The starting dose of SCO-101 is 150 mg 6 daily dosing in a bi-weekly schedule) and may be increased to a maximum of 350 mg (5 cohorts with 50 mg increments). A total of up to 18 patients are anticipated if dose escalation to the 5th cohort. Gemcitabine and nab-paclitaxel is administered according to local standard recommendations once weekly for three weeks followed by one weeks treatment holiday (dosing on day 6, day 13 and day 20). Patients may continue treatment until treatment progression.

Being tested
SCO-101, Gemcitabine, Nab paclitaxel
Keywords
pancreatic, cancer, non-resectable, inoperable, pancreatic adenocarcinoma
Medical subject headings
Neoplasms

What participants receive

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

  • SCO-101Drug

    Oral tablets with a strength of 50 mg or 150 mg according to dose level (cohort). Administered for 6 consequtive days in a bi-weekly schedule in each treatment cycle. Treatment until disease progression.

  • GemcitabineDrug

    Used according to marketing authorisation

  • Nab paclitaxelDrug

    Used according to marketing authorisation

Study groups in NCT04652206
Study groupRoleWhat they receive
SCO-101 in combination with gemcitabine and nab-paclitaxelExperimentalPatients receive escalating doses of SCO-101 in combination with the standard recommended dose of gemcitabine and nab-paclitaxel according to local clinical practice. Gemcintabine and nab-paclitaxel is the recommended treatment for the patient group. Starting dose of SCO-101 is 150 mg. Maximum dose tested is 350 mg. The dose is increased with 50 mg increments between each cohort.
Receives: Drug: SCO-101; Drug: Gemcitabine; Drug: Nab paclitaxel

What is being measured

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

  1. Safety and Tolerability

    Safety and tolerability by assessing the number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until four weeks after end of treatment to evaluate safety of SCO-101 in combination with gemcitabine and nab-paclitaxel determined according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE v.5.0).

    Measured: Through study completion, assessed up to 100 months

  2. Maximum Tolerated Dose

    To determine the Maximum Tolerated Dose (MTD) of SCO-101 in combination with gemcitabine and nab-Paclitaxel by assessment of Dose Limiting Toxicities (DLT) to SCO-101.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Secondary outcomes (5)

  1. Objective Response Rate

    defined as CR and PR using the RECIST v. 1.1

    Measured: Tumor assessment is performed every two treatment cycles (2 months), assessed up to 100 months.

  2. Clinical Benefit Rate (CBR)

    defined as the number of patients obtaining CR, PR, or SD > 16 weeks according to RECIST v.1.1.

    Measured: From benefit (CR, PR or SD > 16 weeks) to progression, assessed up to 100 months

  3. Progression Free Survival (PFS)

    defined as time in months from the date of first study treatment with SCO-101 to the date of disease progression or death from any cause, whichever comes first.

    Measured: From first dosing to progression, assessed up to 100 months

  4. Overall Survival

    defined as time in months from the date of first study treatment to the date of death

    Measured: through study completion, assessed up to 100 months

  5. Pharmacokinetic profile

    Pharmacokinetic profile of SCO-101 alone and in combination with gemcitabine and nab-paclitaxel

    Measured: during the first 14 treatment days in the first treatment cycle.

Timeline

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

  1. First posted3 Dec 2020
  2. Study start27 Oct 2020
  3. Primary completion30 Mar 2022 (estimated)
  4. Study completion15 May 2022 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Standard 3+3 dose escalation design to determine the Maximum Tolerated dose (MTD) of SCO-101 when administered in combination with gemcitabine and nab-paclitaxel, in patients with inoperable pancreatic cancer
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652206
Sponsor's protocol ID
SCO101-002
Other IDs
2020-002627-11
Acronym
PANTAX-Ib
Status last verified
Dec 2021
First submitted
20 Nov 2020
Last updated
29 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shim S, Reinacher-Schick A, Kraeft AL, Per Pfeiffer, Tarpgaard LS, Ettrich TJ, Kestler A, Christensen S, Jandu H, Nawabi M, Roest NL, Damstrup L, Vestlev PM, Brunner N, Stenvang J, Ladekarl M. PANTAX: a phase Ib clinical trial of the efflux pump inhibitor SCO-101 in combination with gemcitabine and nab-paclitaxel in non-resectable or metastatic pancreatic cancer. Invest New Drugs. 2025 Apr;43(2):337-347. doi: 10.1007/s10637-025-01526-7. Epub 2025 Apr 24.

    PubMed 40272619

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCO-101, Gemcitabine and Nab paclitaxel in people with Metastatic Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Adenocarcinoma, run by Scandion Oncology A/S 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 22 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. 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 Denmark, Germany. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Peter M Vestlev, MD (+4522779696, pmv@scandiononcology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability (time frame: Through study completion, assessed up to 100 months). The study lists 2 primary outcomes in all. 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 NCT04652206, which also lists 1 linked publication.

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 29 Dec 2021.

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