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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Malignant Solid Tumor Solid Tumor Metastatic Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY2334737 - Arm A

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.

Group Type EXPERIMENTAL

LY2334737

Intervention Type DRUG

Administered orally

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 then repeated (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met.

Group Type EXPERIMENTAL

LY2334737

Intervention Type DRUG

Administered orally

Interventions

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LY2334737

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No