C14 Study in Oncology Patients With Advanced and/or Metastatic Solid Tumors
This is an open-label study being conducted to determine the metabolism and physiological disposition of radiolabeled LY2603618 after a single dose in patients with advanced and/or metastatic solid tumors.
After a minimum 7-day washout period following the [14C]LY2603618 dose, patients will be allowed to continue to receive continued access to LY2603618 in combination with pemetrexed or gemcitabine as outpatients.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Disposition of [14C]LY2603618 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumors|
- Urinary and fecal excretion of LY2603618 radioactivity over time expressed as a percentage of the total radioactive dose administered [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Plasma pharmacokinetics of LY2603618 and radioactivity (Cmax) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Plasma pharmacokinetics of LY2603618 and radioactivity AUC(0-infinity) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Plasma pharmacokinetics of LY2603618 and radioactivity AUC(0-Tlast) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Relative abundance of LY2603618 and the metabolites of LY2603618 in urine, and feces [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- The number of participants with a tumor response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Single 250 mg intravenous dose of LY2603618 containing [14C] LY2603618.
After the completion of a minimum 7 day wash out period, patients may receive additional doses of LY2603618 in combination as follows:
Patients will be allowed to continue to receive the combination therapy until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
Administered intravenouslyDrug: Pemetrexed
Other Names:Drug: Gemcitabine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296568
|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.|
|Bruderholz, Switzerland, 4101|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT- 5 hours, EST)||Eli Lilly and Company|