Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcit… (NCT04652206) | Clinical Trial Compass
UnknownPhase 1/2
Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.
Denmark, Germany18 participantsStarted 2020-10-27
Plain-language 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. The starting dose of SCO-101 is 150 mg and the dose may be increased to a maximum of 350 mg.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Safety and Tolerability
Timeframe: Through study completion, assessed up to 100 months
2
Maximum Tolerated Dose
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
✕. Treatment with antibiotics for infections or with clinical symptoms of active infection. Patients showing symptoms of CoViD19 must be tested for active CoViD19 infection.