Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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.

SCO-101

Used according to marketing authorisation

Nab paclitaxel

Peter M Vestlev, MD

Morten Ladekarl, Prof., DMSc

Per Pfeiffer, MD

Anke Reinacher-Schick, MD

Thomas Ettrich, MD

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.

The study is an open-label dose escalating phase Ib study of SCO-101 in combination with gemcitabine and nab-paclitaxel. The primary objective is to establish the safety, tolerability and MTD of SCO-101 when combined with gemcitabine and nab-paclitaxel. Secondary objectives are efficacy and to establish PK parameters of SCO-101. The target indication is patients with inoperal pancreatic cancer who are to be treated with gemcitabine and nab-paclitaxel. The study is designed as a standard 3+3 dose escalation study with increasing doses of SCO-101 and a fixed dose (standard regimen) of gemcitabine and nab-paclitaxel. An interim report will be prepared once the last patient in the MTD cohort has completed one treatment cycle. Patients will continue treatment until disease progression to evaluate secondary objectives. One treatment Cycle is 28 days. The starting dose of SCO-101 is 150 mg 6 daily dosing in a bi-weekly schedule) and may be increased to a maximum of 350 mg (5 cohorts with 50 mg increments). A total of up to 18 patients are anticipated if dose escalation to the 5th cohort. Gemcitabine and nab-paclitaxel is administered according to local standard recommendations once weekly for three weeks followed by one weeks treatment holiday (dosing on day 6, day 13 and day 20). Patients may continue treatment until treatment progression.

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

Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.

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.

assessment of biomarkers from blood and tumor

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).

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.

defined as CR and PR using the RECIST v. 1.1

defined as the number of patients obtaining CR, PR, or SD \> 16 weeks according to RECIST v.1.1.

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.

defined as time in months from the date of first study treatment to the date of death

Pharmacokinetic profile of SCO-101 alone and in combination with gemcitabine and nab-paclitaxel

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.	NCT04652206	Metastatic Panc... Locally Advance... Inoperable Dise... Localized Pancr...	SCO-101 Gemcitabine Nab paclitaxel	18 Years -	Scandion Oncology A/S
Clinical Trial to Investigate Safety, Tolerability and MTD for SCO-101 in Combination With Gemcitabine and Nab-paclitaxel in Inoperable Pancreatic Cancer Patients.	NCT04652206	Metastatic Panc... Locally Advance... Inoperable Dise... Localized Pancr...	SCO-101 Gemcitabine Nab paclitaxel	18 Years -	Scandion Oncology A/S

Spots Global Cancer Trial Database for localized pancreatic adenocarcinoma