Conditions: Solid Tumors
Allocation:  | Intervention model: SEQUENTIAL
Enrollment: 31
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: LY573636-sodium intervention 2: Liposomal Doxorubicin
Intervention descriptions: intervention 1: Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28-day cycle.

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 milligrams per square meter (mg/m²) of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion is met. intervention 2: 40 mg/m² on Day 1, given intravenously of each 28-day cycle

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 mg/m² of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion are met.

Protocol document: