Phase 1
Completed N=73
A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread
Malignant Solid Tumor · Solid Tumors · Metastatic Tumor
Source: ClinicalTrials.gov NCT01648764 ↗
Enrolled (actual)
73
Serious AEs
53.4%
Results posted
Jun 2019
Primary outcomePrimary: Recommended Dose for Phase 2 Studies — 90 mg every other day for 21 days
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Dose for Phase 2 Studies |
90 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737 |
188; 315; 250; 225; 279; 469 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC) |
12.1; 30.8; 30.7; 25.4; 54.9; 59.4 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU) |
4990; 7250; 8060; 10800; 9350; 11500 | — |
| SECONDARY Pharmacokinetics: Maximum Plasma Concentration (Cmax) |
53.9; 62.6; 72.4; 91.8; 118; 171 | — |
| SECONDARY Number of Participants With Best Overall Response (BOR) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline |
33.3; 33.3; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Changes in R-R Interval From Baseline |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Pharmacokinetics: Minimum Plasma Concentration (Cmin) |
0.451; 0.319; 0.458; 0.279; 0.392; 0.901 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01648764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.