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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01648764
First received: July 20, 2012
Last updated: November 28, 2012
Last verified: November 2012
  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:


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 April 17, 2014