Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.
1. 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).
2. Maximum Tolerated Dose (Time Frame - At the end of Cycle 1 (each cycle is 28 days)): 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.
Secondary outcome:
1. Objective Response Rate (Time Frame - Tumor assessment is performed every two treatment cycles (2 months), assessed up to 100 months.): defined as CR and PR using the RECIST v. 1.1
2. 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.
3. Progression Free Survival (PFS) (Time Frame - From first dosing to progression, assessed up to 100 months): 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.
4. Overall Survival (Time Frame - through study completion, assessed up to 100 months): defined as time in months from the date of first study treatment to the date of death
5. Pharmacokinetic profile (Time Frame - during the first 14 treatment days in the first treatment cycle.): Pharmacokinetic profile of SCO-101 alone and in combination with gemcitabine and nab-paclitaxel
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
Quelle: ClinicalTrials.gov
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