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The aim on this study is to assess the safety and efficacy of the anti-VEGFR2 monoclonal antibody olinvacimab and the capecitabine in patients with metastatic colorectal carcinoma who failed two prior chemotherapies
Full description
This is a phase lb/ll, multicenter, open label, single arm study to assess efficacy and safety of the anti-VEGFR2 monoclonal antibody olinvacimab and capecitabine in patients with metastatic colorectal cancer who failed two prior standard chemotherapies.
The primary objective of phase lb is to determine maximal tolerated dose (MTD) and recommended phase ll dose (RP2D) of olinvacimab in combination with capecitabine. the primary objective of phase ll is to assess the efficacy of olinvacimab plus capecitabine as a salvage regimen in metastatic colorectal carcinoma.
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Inclusion criteria
Phase Ib: Subjects with a histologically-confirmed, advanced/recurrent colorectal cancer who have progressed on two prior standard chemotherapies Phase II: Histologically or cytologically confirmed colorectal cancer patient who had progressed on, were intolerant of, or were inappropriate for the treatment with fluoropyrimidine, oxaliplatin, irinotecan and targeted agents (If the subject received adjuvant chemotherapy after curative surgery and lymph node dissection for colorectal cancer, the adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.)
Permit previous 2 lines of anti-VEGF blockades
Patient has evaluable disease as per RECIST 1.1. (Measurable lesions are not mandatory for study inclusion.)
Age ≥ 19 years old of male and female
ECOG performance status (PS) 0-1
Adequate bone marrow and organ function as defined by the following laboratory values:
Adequate cardiac function: QTc ≤480 msec; if QTc exceeds 480 msec, subjects can be enrolled if the average QTc value is less than 480 msec by measuring 3 times consecutively in total.
The subject is able to swallow and retain oral medication
Serum β-HCG test negative within 14 days before the first administration of the study treatment (women of childbearing potential only).
Requirement for contraception must be observed by the subject.
Life expectancy of at least 3 months
Subject has signed the Informed Consent Form (ICF) prior to any screening procedures being performed.
Exclusion criteria
Patient has a known or suspicious hypersensitivity to fluoropyrimidines.
Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subject can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug. If monoclonal antibody therapy including anti VEGF agent was given, the subject can be enrolled after four weeks after the last does.
Patients with complete or partial dihydropyrimidine dehydrogenase deficiency.
Serious uncontrolled intercurrent infections
Serious intercurrent medical or psychiatric illness, including active cardiac disease
Active central nervous system (CNS) lesions (i.e., those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without steroid therapy and the evidence of CNS disease progression for more than 4 weeks. However, patients with leptomeningeal metastases are excluded.
History of other primary cancer. Exceptions are as follows:
Patient has not recovered to ≤ grade 1 (except alopecia) from related adverse effects of any prior antineoplastic therapy.
Radiotherapy with a wide field (more than 30% of the bone marrow) of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
Patient who has undergone major surgery ≤ 4 weeks prior to starting study treatment or who has not recovered from adverse effects of such procedure.
Patient has a known positive serology for human immunodeficiency virus (HIV), active Hepatitis B, and/or active Hepatitis C infection. Hepatitis B carriers may be enrolled if prophylactic use of an antiviral agent with minimal interaction with CYP3A4 is administered to inhibit HBV activation (e.g., entecavir, adefovir)
Concomitant medication of strong or moderate inducers or inhibitors of CYP3A4 before the first dose of study treatment (In this case, if the drug is stopped for more than 1 week and changed to another drug that does not affect CYP3A4, then the subject can be enrolled.)
People who are taking BCRP inhibitors, allopurinol, soribudin, brivudine or within 4 weeks of stopping, and taking tegafur/gimeracil/oteracil or within 7 days of stopping
History of allogeneic bone marrow transplantation or organ transplantation
As judged by the Investigator, all other symptoms and associated disease for which the investigator determined that participation in this study is contraindicated (e.g. Infection/inflammation; severe liver dysfunction; bilateral diffuse interstitial lung disease; uncontrolled renal disease; unstable heart and lung disease; hemorrhagic disease; intestinal obstruction; unable to swallow oral pills; social and psychological problems, etc.)
Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial
Primary purpose
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Interventional model
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0 participants in 1 patient group
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Central trial contact
Soohyeon Lee, MD, PhD; Ah Reum Lim, MD
Data sourced from clinicaltrials.gov
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