A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 25 - Any |
Updated: | 2/27/2019 |
Start Date: | November 2007 |
End Date: | April 2011 |
Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin
The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of
LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic
cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B
will consist of an expanded cohort to confirm the dose provided from Part A.
LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic
cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B
will consist of an expanded cohort to confirm the dose provided from Part A.
Inclusion Criteria:
- 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 3 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 (RECIST)
- 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.
Exclusion Criteria:
- 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 discretion of investigator)
- Have one of the following conduction abnormalities: Corrected time between start of Q
wave and end of T wave (QTc) prolongation >450 millisecond (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 or equal to 140 millimeters of Mercury (mm
Hg), and diastolic blood pressure greater than or equal to 90 mm Hg that is not
controlled by medical therapy
- Have 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;
have history of arrhythmia that is symptomatic or requires treatment
- Have chronic atrial fibrillation and/or bradycardia
- Have uncorrected electrolyte disorders including potassium <3.4 molar equivalent per
liter (mEq/L) (<3.4 millimole per liter [mmol/l]), calcium <8.4 milligram per
deciliter (mg/dL) (2.1 mmol/L), or magnesium <1.2 mg/dL (<0.62 mmol/L)
- Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
required)
- Have a hematologic malignancy
- Females who are pregnant or lactating
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