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Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin


Phase 1
25 Years
N/A
Not Enrolling
Both
Advanced Cancer

Thank you

Trial Information

Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose for Phase 2 studies

Outcome Time Frame:

Baseline to study completion

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

11613

NCT ID:

NCT01287520

Start Date:

November 2007

Completion Date:

April 2011

Related Keywords:

  • Advanced Cancer
  • Neoplasm Metastasis
  • Neoplasms

Name

Location

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.Jacksonville, Florida  32256
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.Memphis, Tennessee  38138