A Study of LY2090314 in Patients With Advanced or Metastatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01287520
First received: January 28, 2011
Last updated: June 19, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended dose for Phase 2 studies [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • Alimta
  • LY231514
Drug: Carboplatin
Administered intravenously

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287520

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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 28, 2014