A Study of LY2801653 in Advanced Cancer

Description

The purpose of this study is to determine a safe dose of LY2801653 to be given to patients with advanced cancer and to determine any side effects that may be associated with LY2801653 in this patient population. Efficacy measures will be used to assess the activity of LY2801653 in this patient population.

Study Start Date

November 2009

Estimated Completion Date

November 2017

Interventions

  • Drug: Ramucirumab
  • Drug: Cetuximab
  • Drug: Gemcitabine
  • Drug: Cisplatin
  • Drug: LY2801653

Specialties

  • Internal Medicine: Clinical Pharmacology,Hematology/Oncology
  • Oncology: Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Cancer
  • LY2801653

Study ID

Eli Lilly and Company -- 13008

Status

Unknown

Trial ID

NCT01285037

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

190

Sponsor

Eli Lilly and Company

Inclusion Criteria

  • Diagnosed with advanced and / or metastatic cancer during dose escalation
  • Diagnosed with colorectal, gastric, or papillary renal cell carcinoma during dose confirmation
  • Must be at least 18 years of age
  • Adequate hematologic, renal, and liver functions
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Ability to swallow capsules

Exclusion Criteria

  • Have serious preexisting medical conditions that would preclude participation in the study
  • Have a chronic underlying infection
  • Have symptomatic central nervous system (CNS) malignancy or metastasis
  • Have current acute or chronic leukemia
  • Are pregnant or lactating
  • Have hepatocellular cancer, liver cirrhosis with a Child-Pugh stage of B or higher, or have received a liver transplant
  • Have a history of congestive heart failure with a New York Heart Association class greater than 2, unstable angina, recent myocardial infarction (within 6 months of study enrollment), transient ischemic attacks, stroke, or arterial or venous vascular disease
  • Have a QTc interval greater than 470 msec

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Mount Sinai Medical Center - New York, New York 46.8 miles None None None
Rhode Island Hospital - Providence, Rhode Island 104.1 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles None None None
Thomas Jefferson University - Philadelphia, Pennsylvania 133.3 miles None None None
University of Pennsylvania Hospital - Philadelphia, Pennsylvania 134.5 miles None None None
University of Pennsylvania Hospital - Philadelphia, Pennsylvania 134.5 miles None None None
Georgetown University Medical Center - Washington, District of Columbia 258.0 miles None None None

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