Clinical trial · Interventional
A Study of LY3007113 in Participants With Advanced Cancer
A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer
NCT01463631CI-TRIAL-00034181completedPhase 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)
This study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3007113 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LY3007113
- description
- Study has a dose escalation phase (Part A) and dose confirmation phase (Part B). Participants in the dose escalation phase will receive 1 of 6 doses of LY3007113 administered orally every 12 hours for at least one cycle. Participants in the dose confirmation phase will receive the maximum tolerated dose from the dose escalation phase administered orally every 12 hours for at least 1 cycle. Three days prior to the start of the first cycle, participants will receive 1 dose at their assigned level to allow for the collection of single dose pharmacokinetics. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
- interventionNames
- Drug: LY3007113
Primary outcomes (1)
- measure
- Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)
- timeFrame
- Baseline through Study Completion (up to 170 Days)
- description
- Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease * For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma * For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma * Have the presence of measureable or non-measureable disease (Part A) or measureable disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or the Revised Response Criteria for Malignant Lymphoma * Have adequate hematologic, hepatic and renal function * Have a performance status less than or equal to 2 on the Eastern Cooperative Oncology Group scale * Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents * Have an estimated life expectancy of greater than or equal to 12 weeks * Are able to swallow capsules Exclusion Criteria: * Have an echocardiogram with clinically significant abnormalities * For Dose Escalation (Part A): Have central nervous system malignancy or metastasis * For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy or metastasis * Have an acute leukemia * Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years * Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug
References
Publications (0)
Data not yet available
No reference posted for this study.