A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
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ClinicalTrials.gov Identifier: NCT01287520 |
Recruitment Status
:
Completed
First Posted
: February 1, 2011
Last Update Posted
: June 21, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Drug: LY2090314 Drug: pemetrexed Drug: Carboplatin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: LY2090314/pemetrexed/carboplatin
In Part A, intravenous (IV) doses of LY2090314 starting at 10 mg will be given on day 1 of cycle 1 (28 days) followed by 10 mg dose of LY2090314, 500 mg/m^2 IV dose of pemetrexed, and 5 or 6 AUC IV dose of carboplatin on day 8 of cycle 1. In Cycle 2, pemetrexed and carboplatin will be given on day 1 at same dose administered in cycle 1. In Cycle 3 and beyond, LY2090314, pemetrexed and carboplatin will be given on day 1 in the same dose administered in cycle 1. Cycles 2 and beyond are 21 days in length. Doses of LY2090314 will be escalated until the maximum tolerated dose is reached. In Part B, dose determined by Part A will be administered. Patients may continue the combination treatment if they are receiving therapeutic benefit until they fulfill one of the criteria for discontinuation. |
Drug: LY2090314
Administered intravenously
Drug: pemetrexed
Administered intravenously
Other Names:
Drug: Carboplatin
Administered intravenously
|
- Recommended dose for Phase 2 studies [ Time Frame: Baseline to study completion ]
- Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Days 1, 2, 8, and 9 of Cycle 1, and Days 1 and 2 of Cycle 2, and Day 1 for Cycles 3 and beyond. ]
- Pharmacokinetics, maximum plasma concentration (Cmax) [ Time Frame: Days 1, 2, 8, and 9 of Cycle 1, and Days 1 and 2 of Cycle 2, and Day 1 for Cycles 3 and beyond. ]

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Ages Eligible for Study: | 25 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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.
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 the discretion of the investigator).
- 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 treatment.
- 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 required).
- Have a hematologic malignancy.
- Females who are pregnant or lactating.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287520
United States, Florida | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Tampa, Florida, United States | |
United States, Tennessee | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Nashville, Tennessee, United States |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Chief Medical Officer, Eli Lilly |
ClinicalTrials.gov Identifier: | NCT01287520 History of Changes |
Other Study ID Numbers: |
11613 I2H-MC-JWYA ( Other Identifier: Eli Lilly and Company ) |
First Posted: | February 1, 2011 Key Record Dates |
Last Update Posted: | June 21, 2011 |
Last Verified: | June 2011 |
Additional relevant MeSH terms:
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes Carboplatin Pemetrexed |
Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |