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)
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|ClinicalTrials.gov Identifier: NCT04652206|
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma Locally Advanced Pancreatic Adenocarcinoma Inoperable Disease Localized Pancreatic Adenocarcinoma||Drug: SCO-101 Drug: Gemcitabine Drug: Nab paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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.|
|Actual Study Start Date :||October 27, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||May 15, 2022|
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
Drug: Nab paclitaxel
Used according to marketing authorisation
- 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).
- 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.
- 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
- 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.
- 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.
- 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
- 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
- Novel predictive biomarker feasibility [ Time Frame: assessed from first administration to end of treatment, assessed up to 100 months. ]assessment of biomarkers from blood and tumor
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652206
|Contact: Peter M Vestlev, MDfirstname.lastname@example.org|
|Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Morten Ladekarl, Prof., DMSc email@example.com|
|Principal Investigator: Morten Ladekarl, Prof., DMSc|