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

NCT04652206 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-12-29

No results posted yet for this study

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.

Conditions

  • Metastatic Pancreatic Adenocarcinoma
  • Locally Advanced Pancreatic Adenocarcinoma
  • Inoperable Disease
  • Localized Pancreatic Adenocarcinoma

Interventions

DRUG

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.

DRUG

Gemcitabine

Used according to marketing authorisation

DRUG

Nab paclitaxel

Used according to marketing authorisation

Sponsors & Collaborators

  • Alcedis GmbH

    collaborator INDUSTRY

  • Scandion Oncology A/S

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2022-03-30
Completion
2022-05-15

Countries

  • Denmark
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652206 on ClinicalTrials.gov