A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line

NCT ID: NCT04281524

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2021-10-31

Brief Summary

Peripherally Inserted Central Catheters (PICCs) are commonly used in patients with cancer to administer chemotherapy and supportive care medication. However, PICCs and other medical devices that come into contact with blood increase the risk of blood clots (thrombosis) inside the blood vessels. Conventional blood thinners (anticoagulants) may reduce the risk of thrombosis but they also increase the risk of bleeding. CSL312, a monoclonal antibody that inhibits the activated blood clotting factor 12 (FXIIa) will be assessed for its potential to prevent thrombus formation in subjects with cancer at risk of PICC-associated thrombosis.

Conditions

PICC-associated Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

CSL312 Cohort 1 (Dose 1)

CSL312 administered as IV infusion

Group Type: EXPERIMENTAL

CSL312

Intervention Type: DRUG

CSL312 administered as an IV infusion

CSL312 Cohort 2 (Dose 2)

CSL312 administered as IV infusion

Group Type: EXPERIMENTAL

CSL312

Intervention Type: DRUG

CSL312 administered as an IV infusion

CSL312 Cohort 3 (Dose 3)

CSL312 administered as IV infusion

Group Type: EXPERIMENTAL

CSL312

Intervention Type: DRUG

CSL312 administered as an IV infusion

CSL312 Cohort 4 (Dose 4)

CSL312 administered as IV infusion

Group Type: EXPERIMENTAL

CSL312

Intervention Type: DRUG

CSL312 administered as an IV infusion

Placebo

Placebo administered as IV infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution of 70% 0.9% saline / 30% CSL312 diluent

Interventions

CSL312

CSL312 administered as an IV infusion

Intervention Type: DRUG

Placebo

Solution of 70% 0.9% saline / 30% CSL312 diluent

Intervention Type: DRUG

Other Intervention Names

Garadacimab

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older at the time of providing written informed consent
• Diagnosis of malignancy that requires placement of a PICC within the next 3 weeks for administration of chemotherapy (PICC anticipated to be required for at least 1 month)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 [Oken et al, 1982], and investigator's expectation that performance status will remain 0, 1, or 2 for the duration of the study

Exclusion Criteria

• Active bleeding or with a current clinically significant coagulopathy (eg, international normalized ratio [INR] > 1.5) or clinically significant risk for bleeding (eg, recent intracranial hemorrhage or bleeding peptic ulcer within the last 4 weeks)
• History of venous thrombosis, myocardial infarction or cerebrovascular event within 3 months, or a prothrombotic disorder (eg, antithrombin III, protein C or S deficiency)
• Life expectancy less than study duration (110 days)
• Platelet count of < 20 × 109/L on the day of dose 1 (Day 1) or within 7 days before first dosing
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
• Treatment with antiplatelet or anticoagulant medication, including thrombosis prophylaxis, within 10 days prior to insertion of the PICC
• Chemotherapy regimen that would be expected to drop the platelet count to < 20 × 109/L
• Chemotherapy regimen with heparin mixed into IV bags (eg, dalteparin 2500 IU/day)
• Difficult IV access that would prevent infusion of the IP
• In situ central venous catheter (CVC) or PICC in the 3 months before the Screening Visit. The study PICC must be inserted in the contralateral side, which must be PICC / CVC naïve
• Undergoing dialysis or have another inserted intravascular foreign surface device
• Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≥ 4 × upper limit of normal

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

CSL Behring

Other Identifiers

CSL312_1002

Identifier Type: -

Identifier Source: org_study_id