A Study of LY2940680 in Japanese Participants With Advanc... | NCT01919398

NCT01919398

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I4J-MC-HHBH	Other Identifier	Eli Lilly and Company

Status Module

Label	Type	Description	Intervention Names
LY2940680	Experimental	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.	Drug: LY2940680

Name	Type	Description	Arm Group Labels	Other Names
LY2940680	Drug	Administered orally	LY2940680

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With LY2940680 Dose-Limiting Toxicities (DLT)	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 .	Cycle 1 (28 Days)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)	Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556).	Cycle1 Day1: Predose, 0.5,1,2,4, 6, 8, 10-12 hours; Cycle 1 Day15: Predose, 0.5,1,2,4, 6, 8, 10-12 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. The participant must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1
Have adequate organ function
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy for at least 3 weeks (6 weeks for mitomycin-C or nitrosoureas, 2 weeks for palliative radiation therapy for bone metastasis) prior to study enrollment, and have recovered from the acute effects of any such therapy
Males must agree to use medically approved barrier contraceptive precautions during the study and for 6 months following the last dose of study drug
Females with child bearing potential must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of study drug; have had a negative serum pregnancy test ≤7 days before the first dose of study drug
A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 6 months after the last administration
Have an estimated life expectancy, in the judgment of the investigator, which will permit the participant to complete 2 cycles of treatment
Are able to swallow tablets

Exclusion Criteria:

Have received treatment within 21 days of the study enrollment with any agent that has not received regulatory approval for any indication
Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function and off steroids after cranial irradiation ending at least 14 days prior to enrollment, or after surgical resection performed at least 28 days prior to enrollment
Have known current hematologic malignancies or acute or chronic leukemia
Have a known active fungal, bacterial, and/or known viral infection including human immunodeficiency (HIV) or viral (A, B, or C) hepatitis, potentially affecting the conduct of this study
Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
Have QTc interval of >470 milliseconds (msec) on screening electrocardiogram (ECG)
Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study
Have received any medication that is a strong inhibitor of cytochrome P4503A4 (CYP3A4) within 7 days prior to receiving study drug

Name	Affiliation	Role
1-858-255-5959 Mon-Fri from 9 AM to 5 PM Pacific Time (PST)	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-858-255-5959 Mon - Fri from 9 AM to 5 PM Pacific Time (PST), or speak with your personal physician.		Shizuoka		411-8777	Japan

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: 100 mg LY2940680	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.
FG001	Cohort 2: 200 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.
FG002	Cohort 3: 400 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: 100 mg LY2940680	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.
BG001	Cohort 2: 200 mg LY2940680

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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 .

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

Posted

Count of Participants

Participants

Cycle 1 (28 Days)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: 100 mg LY2940680	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.

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

OG000	Cohort 1: 100 mg LY2940680	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.
OG001	Cohort 2: 200 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.
OG002	Cohort 3: 400 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.