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

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 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