Clinical trial · Interventional
A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer
A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer
NCT02860780CI-TRIAL-00036142completedPhase 1ClinicalTrials.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 main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prexasertib | Drug | Prexasertib | ALIAS |
| ralimetinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: prexasertib + ralimetinib
- description
- Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally. Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally.
- interventionNames
- Drug: prexasertib
- Drug: ralimetinib
- type
- EXPERIMENTAL
- label
- Part B1: prexasertib + ralimetinib (colorectal cancer)
- description
- 60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle.
- interventionNames
- Drug: prexasertib
- Drug: ralimetinib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced or metastatic cancer. * Able to swallow tablets. * For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations. * Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy. Exclusion Criteria: * Active infection (fungal, viral, or bacterial). * Active cancer in your brain or spinal cord. * Acute or chronic leukemia. * Serious heart condition. * Disease that requires immunosuppressant therapy. * Diagnosis of inflammatory bowel disease. * Major small bowel resection that interferes with your body's ability to absorb the oral medicine. * Participated in other clinical trials investigating prexasertib or ralimetinib. * Pregnant or breastfeeding. * Other pre-existing conditions or medical history which your doctor will explain to you.
References
Publications (0)
Data not yet available
No reference posted for this study.