C14 Study in Oncology Patients With Advanced and/or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01296568|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : April 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: LY2603618 Drug: Pemetrexed Drug: Gemcitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Disposition of [14C]LY2603618 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumors|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||February 2012|
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
- Urinary and fecal excretion of LY2603618 radioactivity over time expressed as a percentage of the total radioactive dose administered [ Time Frame: 7 days ]
- Plasma pharmacokinetics of LY2603618 and radioactivity (Cmax) [ Time Frame: 7 days ]
- Plasma pharmacokinetics of LY2603618 and radioactivity AUC(0-infinity) [ Time Frame: 7 days ]
- Plasma pharmacokinetics of LY2603618 and radioactivity AUC(0-Tlast) [ Time Frame: 7 days ]
- Relative abundance of LY2603618 and the metabolites of LY2603618 in urine, and feces [ Time Frame: 7 days ]
- The number of participants with a tumor response [ Time Frame: Baseline to study completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|