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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014