Clinical trial · Interventional
A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread
Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors
NCT01648764CI-TRIAL-00039087completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Tumor | Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY2334737 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LY2334737 - Arm A
- 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.
- interventionNames
- Drug: LY2334737
- type
- EXPERIMENTAL
- label
- LY2334737 - Arm B
- 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.
- interventionNames
- Drug: LY2334737
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.