A Study of LY2603618 in Combination With Gemcitabine in P... | NCT01341457

NCT01341457

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I2I-JE-JMME	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY2603618 + Gemcitabine	Experimental	Gemcitabine 1000 milligrams per meter squared (mg/m^2) administered intravenously on days 1, 8 and 15 of at least one 28-day cycle. 170 or 230 mg LY2603618 administered intravenously on days 2, 9 and 16 of at least one 28-day cycle. Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.	Drug: LY2603618 Drug: Gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
LY2603618	Drug	Administered intravenously	LY2603618 + Gemcitabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose Limiting Toxicity (DLT)	DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 28) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.	Cycle 1 (28 Days)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618		Cycle 1 (days 2 and 16) & 2 (day 2): Predose, End of Infusion, 1 hour (h), 3h, 6h, 24h (days 3 and 17), 48h (days 4 and 18 cycle 1 only), 72h (days 5 and 19)
Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Best Overall Response)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have histological or cytological or imaging evidence of a diagnosis of cancer that is advanced and/or metastatic disease
Participant who is planned to have gemcitabine therapy at the proposed doses because he/she was not able to benefit from standard therapy and/or therapies known to provide clinical benefit or there is no standard therapy for the advanced and/or metastatic disease globally
Have given written informed consent prior to any study-specific procedures
Have adequate hematologic, hepatic and renal function
Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer, including chemotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (42 days for mitomycin C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy
Prior radiation therapy for treatment of cancer is allowed to less than 25% of the bone marrow, and participants must have recovered from the acute toxic effects of their treatment prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 30 days prior to study enrollment
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the study and for 3 months after the last infusion of study drug
Females with child bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have had a negative urine pregnancy test less than 7 days prior to the enrollment
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have an estimated life expectancy of at least 12 weeks

Exclusion Criteria:

Are currently enrolled in, or discontinued within the last 30 days from, a clinical study involving an off-label use of an investigational drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have serious preexisting medical conditions or serious concomitant systemic disorders that would compromise the safety of the participant or his/her ability to complete the study
Have interstitial pneumonitis or pulmonary fibrosis, or previous history of them
Have symptomatic central nervous system malignancy or metastasis
Have current active infection
Females who are pregnant or lactating
Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
Participants with acute or chronic leukemia or with any other disease likely to have a significant bone marrow infiltration
Have previously completed or withdrawn from this study or any other study investigating LY2603618 or any other checkpoint kinase (Chk1) inhibitor
Have known allergy to gemcitabine or LY2603618 or any ingredient of gemcitabine or LY2603618 (like Captisol®)
Have an abnormal electrocardiogram (ECG) result that would put the participant at unnecessary risk in the opinion of the investigator

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Chiba		277-8577

Arm/Group Information

ID	Title	Description
FG000	170 mg LY2603618 + Gemcitabine	Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle. Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.
FG001	230 mg LY2603618 + Gemcitabine	Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 230 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle. Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	170 mg LY2603618 + Gemcitabine	Gemcitabine 1000 milligrams per meter squared (mg/m²) administered intravenously (IV) on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle. Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.

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 Dose Limiting Toxicity (DLT)

DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 28) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

Participants who completed the first cycle of study treatment or who discontinued study treatment due to a DLT. There was one participant in the 170 mg LY2603618 treatment group that had an insufficient number of doses of gemcitabine to evaluate DLT.

Posted

Count of Participants

Participants

Cycle 1 (28 Days)

ID	Title	Description
OG000	170 mg LY2603618 + Gemcitabine	Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle. Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.

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	170 mg LY2603618 + Gemcitabine	Gemcitabine 1000 mg/m² administered IV on days 1, 8 and 15 of at least one 28-day cycle. 170 mg LY2603628 administered IV on days 2, 9 and 16 of at least one 28-day cycle. Participants experiencing benefit may continue on the combination therapy until discontinuation criteria are met.

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides