Clinical trial NCT05251727: Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients
Official title: Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Veloxis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

Detailed description: To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
* ECOG performance status of 0 or 1
* The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
* Able to sufficiently understand the clinical study and give written informed consent

Exclusion Criteria:

* History of major hemorrhage
* High risk of hemorrhage
* History of other malignancies
* Active ulcer
* Patients using anti-coagulants and fibrinolytic drugs
* Active Hepatitis B, or known HBs antigen positive
* Prior treatment history with thrombomodulin alfa
* Administration of another investigational medicinal product within 30 days prior to randomization
* Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
* Patients otherwise deemed as inappropriate to participate in the study by the Investigator

Primary outcomes:
measure: Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: From start of first IMP dose (Cycle 1, Day 1) through End of Treatment (EOT) visit; planned for 6 weeks
measure: Number and Percentage of Participants with Serious TEAEs
timeFrame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
measure: Number and Percentage of Participants with TEAEs Leading to Death
timeFrame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
measure: Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation
timeFrame: From start of first IMP dose (Cycle 1, Day 1) through planned third IMP dose; planned for 4 weeks
measure: Number and Percentage of Participants with Bleeding Events
timeFrame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
measure: Number and Percentage of Participants with Serious Bleeding Events
timeFrame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
measure: Number and Percentage of Participants with Dose Limiting Toxicity (DLT)
timeFrame: From start of first IMP dose (Cycle 1, Day 1) until the start of the third IMP dose; planned for 4 weeks
measure: Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results
timeFrame: 6 weeks
measure: Number and Percentage of Participants with Abnormal Serum Chemistry Results
timeFrame: 6 weeks
measure: Number and Percentage of Participants with Abnormal Coagulation Panel Results
timeFrame: 6 weeks
measure: Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results
timeFrame: 6 weeks
measure: Number and Percentage of Participants with Abnormal Vital Signs
timeFrame: 6 weeks
measure: Number and Percentage of Participants with Anti-ART-123 Antibodies
timeFrame: 6 weeks
Secondary outcomes:
measure: Plasma Concentrations of Thrombomodulin
timeFrame: Cycle 1, Day 1 (each cycle is 14 days)
measure: Plasma Concentrations of 5-fluorouracil (5-FU)
timeFrame: Cycle 1, Day 1 (each cycle is 14 days)
measure: Plasma Concentrations of Oxaliplatin
timeFrame: Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)
measure: Serum Concentrations of Bevacizumab
timeFrame: Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Dept. of Medicine - Hematology/Oncology
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Associates
state: Connecticut
city: Orange City
country: United States
facility: Mid-Florida Hematology & Oncology Centers
state: Florida
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc.
state: Indiana
city: Bethesda
country: United States
facility: American Oncology Partners, P.A.
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Site #115
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Greenville
country: United States
facility: Prisma Health Cancer Institute
state: South Carolina
city: Nashville
country: United States
facility: Nashville Oncology Associates, PC
state: Tennessee
city: Dallas
country: United States
facility: Site #120
state: Texas
city: Houston
country: United States
facility: Site #114
state: Texas
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center
state: Washington
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa-ken
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okyama
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Cancer Center
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Kitakyushu-shi
country: Japan
facility: Kitakyushubyoin Kitakyusyu General Hospital
city: Kobe-shi
country: Japan
facility: Kumpukai Sano Hospital
city: Matsuyama-shi
country: Japan
facility: NHO Shikoku Cancer Center
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
city: Osaka-shi
country: Japan
facility: NHO Osaka National Hospital
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
city: Sapporo-shi
country: Japan
facility: Tonan Hospital
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital
Study officials:
affiliation: Veloxis Pharmaceuticals
name: Libbie McKenzie, MD FASN
role: STUDY_DIRECTOR
References: