A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread - Full Text View

Purpose

The purpose of this study is to evaluate two different dosing regimens of LY2334737 in participants with cancer that is advanced and/or has spread to other parts of the body. Information about side effects will be collected.

Condition	Intervention	Phase
Malignant Solid Tumor Solid Tumor Metastatic Tumor	Drug: LY2334737	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 LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Recommended dose for phase 2 studies [ Time Frame: Baseline through study completion (approximately 49 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Baseline through Cycle 2, Day 1 ] [ Designated as safety issue: No ]
Pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Baseline through Cycle 2, Day 1 ] [ Designated as safety issue: No ]
Best overall response (BOR) [ Time Frame: Baseline to measured disease progression (approximately 49 weeks) ] [ Designated as safety issue: No ]
Progression-free survival (PFS) [ Time Frame: Baseline to measured disease progression or death (approximately 49 weeks) ] [ Designated as safety issue: No ]
Percentage of participants with changes in QT interval (>30 milliseconds) from baseline [ Time Frame: Days 1, 2, 21 and 22 of Cycle 1 ] [ Designated as safety issue: Yes ]
Percentage of participants with changes in R-R interval from baseline [ Time Frame: Days 1, 2, 21, and 22 of Cycle 1 ] [ Designated as safety issue: Yes ]
Pharmacokinetics: Minimum plasma concentration (Cmin) [ Time Frame: Baseline through Cycle 2, Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	September 2008
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LY2334737 - Arm A LY2334737 administered orally at escalating doses (40 mg - 200 mg) every other day for 21 days followed by 7 days without study drug (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.	Drug: LY2334737 Administered orally
Experimental: LY2334737 - Arm B LY2334737 administered orally at escalating doses (40 mg - 200 mg) every day for 7 days followed by 7 days without study drug (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.	Drug: LY2334737 Administered orally

Detailed Description:

This study will consist of a Dose Escalation Phase (Arms A and B) followed by a Dose Confirmation Phase.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of advanced and/or metastatic cancer (including lymphoma) for which no treatment of higher priority exists
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Estimated life expectancy of more than 12 weeks
Have discontinued all previous therapies for cancer for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) and recovered from acute effects of therapy
Have discontinued radiotherapy more than one week before enrolling in the study and have recovered from the acute affects of therapy
Have adequate organ function
Follow your doctor's directions and live close enough to the study site so you can continue to go to the clinic for follow-up
Are willing and able to swallow capsules and follow study procedures
Have given written informed consent prior to any study-specific procedures
Males and females with reproductive potential should use medically approved contraceptive precautions during the study and for 6 months following the last dose of study drug
Females with child-bearing potential must have had a negative urine or serum pregnancy test 7 days prior to the first dose of study drug

Exclusion Criteria:

Have gastrointestinal diseases or prior surgery that may interfere with the absorption of medication taken by mouth
Females who are pregnant or lactating
Symptomatic central nervous system malignancy or metastasis
Known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
Liver cirrhoses or chronic hepatitis
Acute or chronic leukemia
Are currently receiving treatment with valproic acid (VPA) and it's derivatives, or if you have a history of intolerance to VPA
Known hypersensitivity to gemcitabine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648764

Locations

United States, Pennsylvania
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.
Philadelphia, Pennsylvania, United States, 19111
France
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.
Clichy, France, 92118
Germany
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.
Berlin, Germany, 13353
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.
Nürnberg, Germany, 90419

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:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01648764 History of Changes
Other Study ID Numbers:	11967, 2008-000807-28, I1C-MC-JLBE
Study First Received:	July 20, 2012
Last Updated:	November 28, 2012
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013