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

Lilly

Status and phase: Completed; Phase 1

Conditions: Metastatic Tumor; Solid Tumor; Malignant Solid Tumor

Treatments: Drug: LY2334737

Study type: Interventional

Funder types: Industry

Identifiers

NCT01648764

2008-000807-28 (EudraCT Number)

11967

I1C-MC-JLBE (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 effects 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 cirrhosis or chronic hepatitis
• Acute or chronic leukemia
• Are currently receiving treatment with valproic acid (VPA) and its derivatives, or if you have a history of intolerance to VPA
• Known hypersensitivity to gemcitabine

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

LY2334737 - Arm A

Experimental group

Description:

LY2334737 administered orally at escalating doses \[40 milligrams (mg) - 200 mg\] 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.

Treatment:

Drug: LY2334737

LY2334737 - Arm B

Experimental group

Description:

LY2334737 administered orally at escalating doses (40 mg - 200 mg) every day for 7 days followed by 7 days without study drug then repeated (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.

Treatment:

Drug: LY2334737