Dose-Escalation Study of LY573636-sodium and Liposomal Doxorubicin in Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: LY573636-sodium; Liposomal Doxorubicin
Intervention description: 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.; 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.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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