Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.
NCT ID: NCT04652206
Last Updated: 2021-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2020-10-27
2022-05-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
SCO-101
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.
Gemcitabine
Used according to marketing authorisation
Nab paclitaxel
Used according to marketing authorisation
Interventions
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SCO-101
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.
Gemcitabine
Used according to marketing authorisation
Nab paclitaxel
Used according to marketing authorisation
Eligibility Criteria
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Inclusion Criteria
1. Ability to understand and willingness to provide written informed consent before any trial-related activities.
2. Age 18 years or older.
3. Histologically or cytologically verified pancreatic adenocarcinoma.
4. 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.
5. Measurable or non-measurable disease determined by CT scan or MRI, according to RECIST 1.1.
6. Performance status of ECOG ≤ 2 and expected to tolerate the standard recommended (100%) gemcitabine and nab-paclitaxel dose.
7. Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy or treatment with cytotoxic or biologic agents.
8. ≥ 2 weeks must have elapsed since any prior surgery or radiotherapy.
9. 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
10. Life expectancy longer than 3 months.
11. 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.
Exclusion Criteria
1. Concurrent chemotherapy, radiotherapy, or other investigational drug during study period.
2. 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.
3. Difficulty in swallowing tablets.
4. CNS metastases requiring steroids.
5. Treatment with antibiotics for infections or with clinical symptoms of active infection. Patients showing symptoms of CoViD19 must be tested for active CoViD19 infection.
6. Known HIV positivity.
7. Known active hepatitis B or C.
8. 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.
9. Mental status, symptomatic epilepsy or other CNS disease where the investigator assesses the patient not fit for the clinical study.
10. 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.
11. Known hypersensitivity to gemcitabine and/or nab-paclitaxel.
12. Pregnant women or women who are breastfeeding.
13. Prior or present neuropathy \> grade I (NCI-CTCAE v.5.0).
14. Curatively intended treatment.
18 Years
ALL
No
Sponsors
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Alcedis GmbH
INDUSTRY
Scandion Oncology A/S
INDUSTRY
Responsible Party
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Locations
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Aalborg University Hospital
Aalborg, , Denmark
Odense Universitetshospital
Odense, , Denmark
Catholic Hospital Bochum - St. Josef-Hospital
Bochum, , Germany
University Hospital Of Ulm
Ulm, , Germany
Countries
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Central Contacts
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Facility Contacts
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Morten Ladekarl, Prof., DMSc
Role: primary
Per Pfeiffer, MD
Role: primary
Anke Reinacher-Schick, MD
Role: primary
Thomas Ettrich, MD
Role: primary
Other Identifiers
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2020-002627-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SCO101-002
Identifier Type: -
Identifier Source: org_study_id