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

NCT04652206 | Unknown Phase 1 DMC

• 2 other identifiers: SCO101-0022020-002627-11
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

pancreatic; cancer; non-resectable; inoperable; pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

  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).

  Through study completion, assessed up to 100 months

• Maximum Tolerated Dose

  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.

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (5)

• Objective Response Rate

  Tumor assessment is performed every two treatment cycles (2 months), assessed up to 100 months.

• Clinical Benefit Rate (CBR)

  From benefit (CR, PR or SD > 16 weeks) to progression, assessed up to 100 months

• Progression Free Survival (PFS)

  From first dosing to progression, assessed up to 100 months

• Overall Survival

  through study completion, assessed up to 100 months

• Pharmacokinetic profile

  during the first 14 treatment days in the first treatment cycle.

Other Outcomes (1)

• Novel predictive biomarker feasibility

  assessed from first administration to end of treatment, assessed up to 100 months.

Study Arms (1)

SCO-101 in combination with gemcitabine and nab-paclitaxel

EXPERIMENTAL

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.

Drug: SCO-101; Drug: Gemcitabine; Drug: Nab paclitaxel

Interventions

SCO-101 DRUG

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 in combination with gemcitabine and nab-paclitaxel

Gemcitabine DRUG

Used according to marketing authorisation

SCO-101 in combination with gemcitabine and nab-paclitaxel

Nab paclitaxel DRUG

Used according to marketing authorisation

SCO-101 in combination with gemcitabine and nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are required to meet all of the following criteria for enrollment into the study:
• 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.
• Adequate conditions as evidenced by the following clinical laboratory values:
• Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
• Haemoglobin ≥ 6.0 mmol/L
• Platelets ≥ 100 x 109 /L
• Alanine aminotransferase (ALT) ≤ 2.5 x ULN and aspartate aminotransferase (AST) ≤ 2.5 x ULN\*
• Total Serum bilirubin ≤ 1.0 ULN

You may not qualify if:

• Patients meeting any of the following criteria will be excluded from enrollment:
• 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.
• CNS metastases requiring steroids.
• Treatment with antibiotics for infections or with clinical symptoms of active infection. Patients showing symptoms of CoViD19 must be tested for active CoViD19 infection.
• Known HIV positivity.
• Known active hepatitis B or C.
• Clinically significant (i.e. active) cardiovascular disease:
• Stroke, Transient ischemic attack (TIA) or myocardial infarction within ≤ 6 months prior to day 1.
• Unstable angina or NYHA Grade II or greater congestive heart failure (CHF).
• Serious cardiac arrhythmia requiring medication.
• Mental status, symptomatic epilepsy or other CNS disease where the investigator assesses the patient not fit for the clinical study.
• Other medications or conditions that in the Investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results. Other severe medical conditions, including serious heart disease, unstable diabetes, uncontrolled hypercalcemia or previous organ transplants. Participation in another clinical trial with experimental medication within 30 days prior to registration.
• Known hypersensitivity to gemcitabine and/or nab-paclitaxel.

Sponsors & Collaborators

• Scandion Oncology A/S: lead
• Alcedis GmbH: collaborator

Study Sites (4)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Odense Universitetshospital

Odense, Denmark

RECRUITING

Catholic Hospital Bochum - St. Josef-Hospital

Bochum, Germany

RECRUITING

University Hospital Of Ulm

Ulm, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Gemcitabine; Taxes

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations

Central Study Contacts

Peter M Vestlev, MD

CONTACT

+4522779696; pmv@scandiononcology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 3, 2020
• Study Start: October 27, 2020
• Primary Completion: March 30, 2022
• Study Completion: May 15, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); DE (2)