Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors

A Phase 1b, Multicenter, Dose-Escalation Study of LY573636-sodium in Combination With Liposomal Doxorubicin in Patients With Advanced Solid Tumors

The goal of this study is to determine the dose of LY573636-sodium (hereafter referred to as LY573636) that can be administered safely in combination with liposomal doxorubicin in patients with advanced cancer who have failed a prior treatment.

The study consists of a dose escalation phase to the maximum tolerated dose (MTD) and a dose confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have never been treated with doxorubicin.

Inclusion Criteria:

• You must have a histologically confirmed solid malignancy that is unresectable and/or metastatic which has progressed after receiving standard approved chemotherapy
• You must have a solid malignancy for which an anthracycline-based regimen is felt to be a reasonable treatment option
• You must have measurable disease or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
• You must have a serum albumin level greater than or equal to 3.0 grams/deciliter (g/dL) (30 g/L)
• You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• You must have tumor progression after receiving standard/approved chemotherapy
• You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
• Women must be sterile, post-menopausal or on a contraception and men must be sterile or on contraception
• Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory
• Ovarian patients in the confirmation phase must have failed to achieve at least a partial response to a first-line platinum-based therapy (platinum-refractory) or have progression in less than 6 months after a response to a first-line platinum-based therapy (platinum-resistant)
• Ovarian patients in the confirmation phase must have measurable disease by RECIST
• Ovarian patients in the confirmation phase must be liposomal doxorubicin or doxorubicin naive and not amendable to curative therapy

Exclusion Criteria:

• You cannot have received other investigational drugs within the last 28 days
• You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections
• You cannot have current hematologic malignancies, acute or chronic leukemia, or brain metastasis
• You cannot currently be receiving warfarin (Coumadin®) therapy
• You cannot have known positive test results in human immunodeficiency, hepatitis B surface antigen or hepatitis C antibodies
• You cannot have a history of cardiac disease or clinical evidence of congestive heart failure
• Ovarian patients in the confirmation phase who have received 2 or more cytotoxic regimens for platinum-resistant disease
• You cannot currently be receiving amiodarone, quinidine, propofol, and clozapine
• If you are taking esomeprazole or pantoprazole you must be able to stop taking this medication within 72 hours before and after LY573636 administration