Clinical trial · Interventional
A Phase 1 Study in Participants With Advanced Cancer
A Phase 1 Study of LY2606368 in Patients With Advanced Cancer
NCT01115790CI-TRIAL-00022077completedPhase 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 primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of prexasertib (an inhibitor of checkpoint kinase 1\[chk 1\]) in participants with advanced or metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three different groups of participants; those with squamous cell cancer of the head and neck that has recurred or spread to other parts of the body, those with squamous non-small cell lung cancer that has recurred or spread, and those with squamous cell cancer of the anus that is not curable by existing therapy.
Conditions
Conditions (6)
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 |
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Carcinoma, Squamous Cell of Head and Neck | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Lung Squamous Cell Carcinoma Stage IV | Lung Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prexasertib | Drug | Prexasertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prexasertib
- interventionNames
- Drug: Prexasertib
Primary outcomes (3)
- measure
- Determination of a Recommended Phase 2 Dosing Regimen: Maximum Tolerated Dose (Parts A and B)
- timeFrame
- Time of first dose until last dose (estimated as up to 156 weeks)
- measure
- Determination of Clinically Significant Safety Effects (Parts A and B)
- timeFrame
- Time of first dose until last dose (estimated as up to 156 weeks)
- measure
- Percentage of Participants With a Complete or Partial Response (Overall Response Rate) (Part C)
- timeFrame
- Baseline until disease progression or death from any cause (estimated as up to 24 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed * Have adequate organ function * Prior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment * Part A: Must have diagnosis of cancer that is advanced or metastatic * Part B: Must have histologically confirmed squamous cell cancer of the head and neck or must have squamous cell cancer of any tumor type * Part C: Must have histological diagnosis of squamous cell cancer of the head and neck, histological or cytological diagnosis of squamous non-small-cell lung cancer, or histological diagnosis of Stage IIIB (N2 or N3) or Stage IV squamous cell cancer of the anus that is not curable by local therapy * Must be available during the duration of the study and willing to follow the study procedures * If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug * If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breast feeding Exclusion Criteria: * Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment * Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C * Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months * Must not have systolic blood pressure \<90 millimeters of mercury (mmHg) or recurrent symptomatic orthostatic hypotension * Must not have a family history of long QTc syndrome or be taking drugs known to cause QTc prolongation or Torsades de Pointes * Must not have a serotonin-secreting carcinoid tumor or a prior history of drug-induced serotonin syndrome * Must not have acute leukemia
References
Publications (2)
- DERIVEDHong DS, Moore K, Patel M, Grant SC, Burris HA 3rd, William WN Jr, Jones S, Meric-Bernstam F, Infante J, Golden L, Zhang W, Martinez R, Wijayawardana S, Beckmann R, Lin AB, Eng C, Bendell J. Evaluation of Prexasertib, a Checkpoint Kinase 1 Inhibitor, in a Phase Ib Study of Patients with Squamous Cell Carcinoma. Clin Cancer Res. 2018 Jul 15;24(14):3263-3272. doi: 10.1158/1078-0432.CCR-17-3347. Epub 2018 Apr 11. PMID 29643063
- DERIVEDHong D, Infante J, Janku F, Jones S, Nguyen LM, Burris H, Naing A, Bauer TM, Piha-Paul S, Johnson FM, Kurzrock R, Golden L, Hynes S, Lin J, Lin AB, Bendell J. Phase I Study of LY2606368, a Checkpoint Kinase 1 Inhibitor, in Patients With Advanced Cancer. J Clin Oncol. 2016 May 20;34(15):1764-71. doi: 10.1200/JCO.2015.64.5788. Epub 2016 Apr 4. PMID 27044938