A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/15/2012 |
| Start Date: | September 2008 |
| End Date: | August 2012 |
| Contact: | There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or |
| Phone: | 1-317-615-4559 |
Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors
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.
This study will consist of a Dose Escalation Phase (Arms A and B) followed by a Dose
Confirmation Phase.
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
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