A Phase 1 Multicenter, Dose-escalation Study of LY573636-Sodium in Combination With 1) Gemcitabine HCl or 2) Docetaxel or 3) Temozolomide or 4) Cisplatin, or 5) Erlotinib in Patients With Advanced Solid Tumors
- Patients who have histologically confirmed solid malignancy or lymphoma that is
unresectable and/or metastatic for which monotherapy with gemcitabine HCl, docetaxel,
temozolomide, cisplatin, or erlotinib would otherwise be appropriate
- Must have tumor progression after receiving standard/approved chemotherapy or limited
- Must have measurable or nonmeasurable disease
- Have given written informed consent prior to any study-specific procedures
- Must have adequate hepatic, hematologic and renal function
- Must have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, cancer-related hormonal therapy or other investigational therapy for at
least 4 weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and
recovered from the acute effects of therapy. Endocrine therapies for the treatment
of prostate cancer may be continued, at the discretion of the investigator. Whole
brain radiation must have been completed 90 days before starting study therapy.
Patients without evidence of brain metastases who have received prophylactic whole
brain irradiation as part of standard of care for small cell lung cancer may be
included in the study with a shorter washout period pending approval by the Lilly
- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 6 months following the last dose
of study drug.
- Females with child-bearing potential must have had a negative serum pregnancy test
within 7 days prior to the first dose of study drug.
- Must have a serum albumin level greater than or equal to 3.0 g/dL (30 g/L).
- Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group
- Have received treatment within 30 days of the initial dose of study drug with a drug
that has not received regulatory approval for any indication
- Have serious preexisting medical conditions that in the opinion of the investigator
would preclude participation in the study
- Patients with active central nervous system or brain metastasis at the time of study
entry. Patients with signs or symptoms of neurological compromise should have
appropriate radiographic imaging performed before study entry to rule out brain
metastasis. Patients with stable CNS metastasis not requiring steroids may be
- Have a current hematologic malignancy (other than lymphoma)
- Patients with serious concomitant disorders, including active bacterial, fungal, or
viral infection, incompatible with the study)
- Patients actively receiving warfarin (Coumadin®) therapy
- Patients who have previously completed or withdrawn from any study investigating
- Patients with a known hypersensitivity to one of the combination drugs cannot be
enrolled to the treatment arm which includes that chemotherapeutic combination
- Females who are pregnant or breast feeding
- Have known positive test results of HIV, hepatitis B, or hepatitis C
- Patients receiving amiodarone, quinidine, propofol, or clozapine.
- Patients receiving treatment with strong or moderate inhibitors of CYP2C19, including
proton-pump inhibitors (PPIs). Esomeprazole or pantoprazole are allowed if not
administered 72 hours before or after LY573636 administration.