A phase I, open-label, two-stage, randomized, crossover, comparative pharmacokinetic and safety study of two formulations of CO-1.01 for injection in patients with advanced solid tumors. - Phase I PK study of CO-1.01 in patients with advanced solid tumors.

Clovis Oncology Inc0 个研究点目标入组 21 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Patients must satisfy all of the following criteria:
•Diagnosis with a histologically confirmed solid tumor malignancy that is metastatic or unresectable for which there are no standard curative or palliative treatment options available and for which CO-1.01 treatment would be appropriate
•Life expectancy of at least 3 months
•Performance Status (ECOG) 0 or 1
•Age >=18 years
•Adequate hematological and biological function, confirmed by the following laboratory values:
•Bone Marrow Function
•* Absolute neutrophil count (ANC) >=1.5 × 109/L
•* Platelets >100.0 × 109/L
•* Hemoglobin >=9 g/dL (or 5.6 mmol/L)
•Hepatic Function
•* AST <= 3 × upper limit of normal (ULN); if liver metastases, <=5 × ULN
•* Bilirubin <=2 × ULN
•* Albumin >3 g/dL (or 30 g/L)
•Renal Function
•*Serum creatinine <=1.5 × ULN
•Written consent on an Institutional Review Board/Independent Ethics Committee-approved IC Form prior to any study-specific evaluation

•Any of the following criteria will exclude patients from study participation:
•Clinically significant abnormal 12-lead ECG or QTcF >450 msec (males) or >470 msec (females), PR >240 msec, or a QRS >110 msec
•Family history of long QT syndrome
•Implantable pacemaker or implantable cardioverter defibrillator
•Symptomatic brain metastases
•Concomitant treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment [except corticosteroids and megesterol acetate], or immunotherapy) <=14 days prior to CO-1.01
•Treatment with a previous regimen of CO-1.01 within 30 days of randomization
•Treatment with any medication known to produce QT prolongation (see Appendix 4)
•Surgical procedures are not allowed <=14 days prior to administration of CO 1.01. in all cases, the patient must be sufficiently recovered and stable
•History of allergy to gemcitabine or eggs
•Females who are pregnant or breastfeeding
•Refusal to use adequate contraception for fertile patients (females and males) for 6 months after the last dose of CO-1.01
•Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism)
•Any other reason the investigator considers the patient should not participate in the study

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