- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04652206
Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients. (PANTAX-Ib)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Peter M Vestlev, MD
- Phone Number: +4522779696
- Email: pmv@scandiononcology.com
Study Locations
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-
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Aalborg, Denmark, 9000
- Recruiting
- Aalborg University Hospital
-
Contact:
- Morten Ladekarl, Prof., DMSc
- Email: morten.ladekarl@rn.dk
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Principal Investigator:
- Morten Ladekarl, Prof., DMSc
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Odense, Denmark
- Recruiting
- Odense Universitetshospital
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Contact:
- Per Pfeiffer, MD
- Email: per.pfeiffer@rsyd.dk
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Principal Investigator:
- Per Pfeiffer, MD
-
-
-
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Bochum, Germany
- Recruiting
- Catholic Hospital Bochum - St. Josef-Hospital
-
Contact:
- Anke Reinacher-Schick, MD
- Email: anke.reinacher@rub.de
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Principal Investigator:
- Anke Reinacher-Schick, MD
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Ulm, Germany
- Recruiting
- University Hospital of Ulm
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Contact:
- Thomas Ettrich, MD
- Email: thomas.ettrich@uniklinik-ulm.de
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Principal Investigator:
- Thomas Ettrich, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SCO-101 in combination with gemcitabine and nab-paclitaxel
Patients 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. |
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.
Used according to marketing authorisation
Used according to marketing authorisation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability
Time Frame: Through study completion, assessed up to 100 months
|
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).
|
Through study completion, assessed up to 100 months
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Maximum Tolerated Dose
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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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.
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At the end of Cycle 1 (each cycle is 28 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: Tumor assessment is performed every two treatment cycles (2 months), assessed up to 100 months.
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defined as CR and PR using the RECIST v. 1.1
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Tumor assessment is performed every two treatment cycles (2 months), assessed up to 100 months.
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Clinical Benefit Rate (CBR)
Time Frame: From benefit (CR, PR or SD > 16 weeks) to progression, assessed up to 100 months
|
defined as the number of patients obtaining CR, PR, or SD > 16 weeks according to RECIST v.1.1.
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From benefit (CR, PR or SD > 16 weeks) to progression, assessed up to 100 months
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Progression Free Survival (PFS)
Time Frame: From first dosing to progression, assessed up to 100 months
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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.
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From first dosing to progression, assessed up to 100 months
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Overall Survival
Time Frame: through study completion, assessed up to 100 months
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defined as time in months from the date of first study treatment to the date of death
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through study completion, assessed up to 100 months
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Pharmacokinetic profile
Time Frame: during the first 14 treatment days in the first treatment cycle.
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Pharmacokinetic profile of SCO-101 alone and in combination with gemcitabine and nab-paclitaxel
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during the first 14 treatment days in the first treatment cycle.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Novel predictive biomarker feasibility
Time Frame: assessed from first administration to end of treatment, assessed up to 100 months.
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assessment of biomarkers from blood and tumor
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assessed from first administration to end of treatment, assessed up to 100 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
Other Study ID Numbers
- SCO101-002
- 2020-002627-11 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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