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Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors

Phase 1
18 Years
Not Enrolling
Malignant Solid Tumor, Solid Tumor, Metastatic Tumor

Thank you

Trial Information

Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose for phase 2 studies

Outcome Time Frame:

Baseline through study completion (approximately 49 weeks)

Safety Issue:


Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

November 2012

Related Keywords:

  • Malignant Solid Tumor
  • Solid Tumor
  • Metastatic Tumor
  • Neoplasm Metastasis
  • Neoplasms



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.Dunmore, Pennsylvania  18512