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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

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