Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Cohort 1: 100 mg LY2940680 administered orally daily in 28-day cycles. Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles. Cohort 3: 400 mg LY2940680 administered orally daily in 28-day cycles.

Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.

LY2940680

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The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to the global recommended dose in Japanese participants with advanced solid cancers.

A Study of LY2940680 in Japanese Participants With Advanced Cancers

A Phase 1 Study of LY2940680 in Japanese Patients With Advanced Solid Tumors

DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and meets any one of the following criteria based on NCI CTCAE,version 4.0): Grade(Gr) 3 nonhematological toxicity(tox) with exceptions for made for nausea(ns),vomiting(vm),constipation(cp),diarrhea(dr),fatigue(ft),anorexia(an),alopecia or electrolyte-abnormality(eab) that is manageable with appropriate care.If \>Gr 3 ns,vm,cp,dr,ft,an,or eab persists for\>2 days with maximal supportive intervention,the event was declared a DLT.Transient(≤5 days) Gr 3 liver enzyme elevations,without evidence of other hepatic injury.Gr 3 thrombocytopenia(throm) requiring platelet transfusion or Gr 4 throm.Gr 4 neutropenia of \>5 days duration.Febrile neutropenia(ANC\<1,000/mm3 with a single temperature(temp) of \>38.3 degrees C or a sustained temp of ≥38 degrees C for more than one hour).Tox requiring dose omissions of \>5 days or significant \& deemed by the primary investigator(PI) \& sponsor(sp) to be dose limiting .

Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556).

Pharmacokinetics (PK): Area Under the Concentration time Curve From 0 to 24 Hours (AUC\[0-24\]) of LY2940680 and a Major Metabolite of LSN3185556.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size (\<10 millimeter \[mm\] short axis). PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.

Percentage Change From Baseline in Gene Expression Level of Hedgehog (Hh) Regulated Genes (Gli1) in Skin.

Eli Lilly and Company

Cohort 1: 100 mg LY2940680 administered orally once daily in 28-day cycles.

Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.

Cohort 1: 100 mg LY2940680

Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles.

Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.

Cohort 2: 200 mg LY2940680

Cohort 3: 400 mg LY2940680 administered orally once daily in 28-day cycles.

Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.

Cohort 3: 400 mg LY2940680

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

All participants who received at least one dose of study drug.

Chief Medical Officer

Number of Participants With LY2940680 Dose-Limiting Toxicities (DLT)

LY2940680:Cycle 1 Day 1

LY2940680:Cycle 1 Day 15

LSN3185556:Cycle 1 Day 1

LSN3185556:Cycle 1 Day 15

All participants who received at least one dose of study drug who had evaluable PK data.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)

Pharmacokinetics (PK): Area Under the Concentration Time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556

Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])

All participants who received at least one dose of study drug and evaluable PD data.

Spots Global Cancer Trial Database for A Study of LY2940680 in Japanese Participants With Advanced Cancers

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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