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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34352

Enrollment

Registered

2011-01-06

Start date

2011-04-04

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced solid neoplasm advanced solid tumors

Interventions

CO-1.01 will be administered as a 30 ± 3 min i.v. infusion under medical supervision. All treatment cycles are 28 days long with CO-1.01 doses administered on Days 1, 8 and 15. CO-1.01 Formulation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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 g/dL (or 30 g/L) Renal Function *Serum creatinine

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
•Ratio of the AUC0-* of the two formulations of CO-1.01 given as a 30 min i.v. infusion at 1250 mg/m2	—

Secondary

Measure	Time frame
Secondary endpoints: •PK of CO-1.01 and metabolites in plasma and urine after 1250 mg/m2 CO-1.01 given as a single 30 min i.v. infusion •QT/QTc interval of the ECG •Relationship between plasma concentration of CO-1.01 and QT/QTc interval of the ECG •Drug tolerability and toxicity using clinical AE monitoring and clinical laboratory testing Exploratory •Tumor response (according to RECIST 1.1) •Blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides	—

Measure

Time frame

Secondary endpoints: •PK of CO-1.01 and metabolites in plasma and urine after 1250 mg/m2 CO-1.01 given as a single 30 min i.v. infusion •QT/QTc interval of the ECG •Relationship between plasma concentration of CO-1.01 and QT/QTc interval of the ECG •Drug tolerability and toxicity using clinical AE monitoring and clinical laboratory testing Exploratory •Tumor response (according to RECIST 1.1) •Blood concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)