Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin
- Have a performance status of less than or equal to 2 on the Eastern Cooperative
Oncology Group (ECOG) scale
- Have a life expectancy of greater than or equal to 12 weeks
- Males and females with reproductive potential agree to use medically approved
contraceptive precautions during the trial and for three months following the last
dose of study drug
- Have histological or cytological evidence of a diagnosis of cancer that is advanced
and/or metastatic disease for which no proven effective therapy exists.
- Have the presence of measurable or nonmeasurable disease as defined by the Response
Evaluation Criteria in Solid Tumors.
- Have adequate hematologic, hepatic, and renal function.
- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, cancer-related hormonal therapy, or other investigational therapy for
at least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
and recovered from the acute effects of therapy.
- 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 (left to the discretion of the
- Have one of the following conduction abnormalities: QTc prolongation >450 msec on
screening electrocardiogram (ECG), previous history of QTc prolongation with another
medication that required discontinuation, congenital long-QT-syndrome, or left bundle
branch block (LBBB).
- Are taking any concomitant medication that may cause QTc prolongation, or induce
Torsades de Pointes.
- Have systolic blood pressure greater than/equal to 140 mm Hg, and diastolic blood
pressure greater than/equal to 90 mm Hg that is not controlled by medical therapy.
- Have a serious cardiac condition, such as myocardial infarction within 6 months,
angina, or heart disease, as defined by the New York Heart Association Class II or
higher. Patients with a history of arrhythmia which is symptomatic or requires
- Have chronic atrial fibrillation and/or bradycardia.
- Have uncorrected electrolyte disorders including potassium <3.4 mEq/L (<3.4 mmol/l),
calcium <8.4 mg/dL (2.1 mmol/L), or magnesium <1.2 mg/dL (<0.62 mmol/L).
- Have symptomatic central nervous system malignancy or metastasis (screening not
- Have a hematologic malignancy.
- Females who are pregnant or lactating.