A Study of LY2090314 in Patients With Advanced or Metastatic Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: LY2090314 Drug: pemetrexed Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
- Recommended dose for Phase 2 studies [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | November 2007 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT01287520 History of Changes |
| Other Study ID Numbers: | 11613, I2H-MC-JWYA |
| Study First Received: | January 28, 2011 |
| Last Updated: | June 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pemetrexed Carboplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013