A Phase 2 Trial of SCO-101 in Combination With FOLFIRI for Patients With Metastatic Colorectal Cancer (mCRC) With Acquired Resistance to FOLFIRI

NCT04247256 | Unknown Phase 1

• 1 other identifier: SCO101-001
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 12

Brief Summary

This study evaluates the combination of SCO-101 to FOLFIRI for the treatment of metastatic colorectal cancer patients who have developed resistance to FOLFIRI treatment. The study is divided in two parts, where the first part evaluates the safety and toxicity of increasing doses of SCO-101 in combination with FOLFIRI at the same dose as the patient has previously developed resistance to. The second part of the study evaluates the safety and efficacy of the combination of FOLFIRI and SCO-101 at the dose level established in the first part.

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal; cancer; resistant; FOLFIRI; metastatic

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of combination of SCO-101 and FOLFIRI

  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 FOLFIRI determined according to CTCAE version 5.0

  4 cycles (each cycle is 2 weeks)

• Maximum Tolerated Dose

  Maximum tolerated dose (MTD) by evaluation of dose-limiting toxicities (DLTs) of SCO-101 in combination with FOLFIRI evaluated by CTCAE v. 5.0 (part 1 only)

  1 cycle (each cycle is 2 weeks)

• Objective Response Rate

  Objective response rate (ORR) defined as CR and PR using the RECIST v. 1.1

  4 cycles (each cycle is 2 weeks)

Secondary Outcomes (10)

• Progression Free Survival (PFS)

  Start of treatment to first objective sign of progression, assessed up to 100 months

• Duration of Response

  From first response to progression, assessed up to 100 months

• Duration of Response compared to prior Duration of response

  From first response to progression, assessed up to 100 months

• Overall Survival

  Up to 2 years

• Clinical Benefit Rate

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

Study Arms (1)

Treatment arm

EXPERIMENTAL

SCO-101 in combination with FOLFIRI

Drug: FOLFIRI Protocol; Drug: SCO-101

Interventions

FOLFIRI Protocol DRUG

FOLFIRI standard treatment on day 5 to 7 (both days included) of a 14 day period. repeated bi-weekly

Treatment arm

SCO-101 DRUG

Investigational Medicinal Product, oral tablet administered on day 1 to 6 (both days included) of a 14 day period. repeated bi-weekly

Treatment arm

Eligibility Criteria

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

You may qualify if:

• Ability to understand and willingness to provide written informed consent before any trial-related activities.
• Age 18 years or older.
• Histologically verified colorectal adenocarcinoma.
• Non-resectable mCRC in patients A. Stage 1 only: with or without known BRAF, KRAS or repair enzyme mutations. B. Stage 2 and stage 3 only: without known BRAF, KRAS or repair enzyme mutations
• A. Stage 1 only: Documented progressive disease on FOLFIRI treatment regimen (with or without antiangiogenetic and EGFR inhibitory biological treatment).
• B. Stage 2 and stage 3 only: Documented progressive disease with a prior benefit (SD for more than 16 weeks, or CR or PR) on FOLFIRI treatment regimen (with or without antiangiogenetic and EGFR inhibitory biological treatment).
• Maximum reduction of 33% in prior dose of FOLFIRI.
• No indication for treatment with an oxaliplatin-containing treatment regimen. The patient may have received oxaliplatin treatment after treatment with FOLFIRI.
• A. Stage 1 only: Evaluable disease by CT scan or MRI. B. Stage 2 and stage 3 only: Measurable disease by CT scan or MRI, according to RECIST. 1.1.
• Performance status of ECOG ≤ 1.
• 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.
• Adequate conditions as evidenced by the following clinical laboratory values:
• Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
• Haemoglobin ≥ 6.0 mmol/L

You may not qualify if:

• Concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
• Malabsorption syndrome or previous surgeries with resection of the stomach or small intestine, whereby absorption of SCO-101 may be affected. This includes patients with ileostomy.
• Difficulty in swallowing tablets.
• Clinical symptoms of CNS metastases requiring steroids.
• Any active infection requiring parenteral or oral antibiotic treatment.
• Known HIV positivity.
• Known active hepatitis B or C.
• Clinical significant (i.e. active) cardiovascular disease:
• Stroke within ≤ 6 months prior to day 1
• Transient ischemic attach (TIA) within ≤ 6 months prior to day 1
• Myocardial infarction within ≤ 6 months prior to day 1
• Unstable angina
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF)
• Serious cardiac arrhythmia requiring medication
• Mental status is not fit for clinical study or CNS disease including symptomatic epilepsy.

Sponsors & Collaborators

• Scandion Oncology A/S: lead
• TFS Trial Form Support: collaborator

Study Sites (12)

Aalborg Universitetshospital - Region Nordjylland

Aalborg, Denmark

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Hillerød Hospital

Hillerød, Denmark

RECRUITING

Sjællands Universitetshospital, Roskilde

Roskilde, Denmark

RECRUITING

Sygehus Sønderjylland

Sønderborg, Denmark

RECRUITING

Vejle Sygehus

Vejle, Denmark

NOT YET RECRUITING

Charité

Berlin, Germany

NOT YET RECRUITING

Catholic Hospital Bochum - St. Josef-Hospital

Bochum, Germany

NOT YET RECRUITING

University Hospital Of Ulm

Ulm, Germany

NOT YET RECRUITING

Hospital de la Santa Creu in Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Valle de Hebrón

Barcelona, Spain

NOT YET RECRUITING

Hospital Clínico Universitario in Valencia

Valencia, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacob Hagen Vasehus Schou, MD

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter M Vestlev, MD

CONTACT

+45 22779696; 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: This is a multi-center, open label, dose escalation, Phase 2 study of SCO-101 in combination with FOLFIRI in up to 50 mCRC patients. Cohorts of FOLFIRI-resistant mCRC patients will be treated with SCO-101 in combination with FOLFIRI . Patients to be enrolled should previously have had either complete response (CR), partial response (PR), or stable disease (SD) (\>16 weeks) on FOLFIRI. The study is separated in two parts. Part 1 is a dose escalation part with a standard 3+3 design, designed to evaluate the safety and toxicity of the combination of SCO-101 and FOLFIRI, and to identify the maximum tolerated dose (MTD). A maximum of 5 cohorts have been planned. Starting dose of SCO-101 is 150 mg (cohort 1) and maximum dose is 350 mg (cohort 5). Part 2 is the efficacy part, where patients are treated with the MTD dose identified in the first part and evaluated for efficacy and safety of the combination SCO-101 plus FOLFIRI.

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: May 14, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 2, 2022

Record last verified: 2021-12

Locations

DE (3); DK (6); ES (3)