Safety and Pharmacokinetic Profiles of Two Formulations of CO-1.01 in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the pharmacokinetic and safety profiles of two formulations of CO-1.01 in patients with Advanced Solid Tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.

Criteria

Inclusion Criteria:

• Diagnosis with a histologically confirmed solid tumor malignancy that is metastatic or unresectable for which there is no standard curative or palliative treatment option 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

• Written consent on an Institutional Review Board/Independent Ethics Committee-approved IC Form prior to any study-specific evaluation

Exclusion Criteria:

• Clinically significant abnormal 12-lead ECG or QTcF>450msec (males) or >470 msec (females), PR>240 msec, or a QRS>110msec

• Family history of long QT syndrome

• Implantable pacemaker or implantable cardioverter defibrillator

• Symptomatic brain metastases

• Concomitant treatment with prohibited medications

• Treatment with a previous regimen of CO-1.01 within 30 days or randomization

• Treatment with any medication known to produce QT prolongation

• 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 of 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