A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread

Phase 1 Dose Escalation Study of LY2334737 Using 2 Dosing Regimens in Patients With Advanced and/or Metastatic Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01648764

Enrollment

Registered

2012-07-24

Start date

2008-09-30

Completion date

2012-11-30

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Solid Tumor, Metastatic Tumor, Solid Tumor

Brief summary

The purpose of this study is to evaluate two different dosing regimens of LY2334737 in participants with cancer that is advanced and/or has spread to other parts of the body. Information about side effects will be collected.

Detailed description

This study will consist of a Dose Escalation Phase (Arms A and B) followed by a Dose Confirmation Phase.

Interventions

DRUGLY2334737

Administered orally

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of advanced and/or metastatic cancer (including lymphoma) for which no treatment of higher priority exists * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Estimated life expectancy of more than 12 weeks * Have discontinued all previous therapies for cancer for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) and recovered from acute effects of therapy * Have discontinued radiotherapy more than one week before enrolling in the study and have recovered from the acute effects of therapy * Have adequate organ function * Follow your doctor's directions and live close enough to the study site so you can continue to go to the clinic for follow-up * Are willing and able to swallow capsules and follow study procedures * Have given written informed consent prior to any study-specific procedures * Males and females with reproductive potential should use medically approved contraceptive precautions during the study and for 6 months following the last dose of study drug * Females with child-bearing potential must have had a negative urine or serum pregnancy test 7 days prior to the first dose of study drug

Exclusion criteria

* Have gastrointestinal diseases or prior surgery that may interfere with the absorption of medication taken by mouth * Females who are pregnant or lactating * Symptomatic central nervous system malignancy or metastasis * Known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) * Liver cirrhosis or chronic hepatitis * Acute or chronic leukemia * Are currently receiving treatment with valproic acid (VPA) and its derivatives, or if you have a history of intolerance to VPA * Known hypersensitivity to gemcitabine

Design outcomes

Primary

Measure	Time frame	Description
Recommended Dose for Phase 2 Studies	Baseline up to 28 days postdose in Cycle 1 (28-day cycle)	Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which \<2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.

Secondary

Measure	Time frame	Description
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle	AUC over the dosing interval (AUC0-Ƭ) of LY2334737 for Arm A (single dose) is 0 to 48 hours postdose. AUC0-Ƭ of LY2334737 for Arm B (multiple doses) is 0 to 24 hours postdose and AUC time 0 to infinity (AUC0-∞) for LY2334737.
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours post dose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours post dose of 28-day cycle	AUC over the dosing interval (AUC0-Ƭ) of dFdC (a metabolite of LY2334737) for Arm A (following a single dose of LY2334737) AUC0-Ƭ is 0-48 hours postdose, Arm B (following multiple doses of LY2334737) AUC 0-Ƭ is 0-24 hours postdose and AUC from time 0 to infinity (AUC0-∞).
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle	Daily AUC from time 0 to 24 hours (AUC 0-24) of dFdU (a metabolite of LY2334737) for Arm A (single dose of LY2334737) and Arm B (multiple doses of LY2334737).
Pharmacokinetics: Maximum Plasma Concentration (Cmax)	Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle	Cmax for LY2334737 and its metabolites 2'2'-difluorodeoxycytidine (dFdC) and difluorodeoxyuridine (dFdU).
Progression-Free Survival (PFS)	Baseline to measured disease progression or death up to 33 weeks	PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Due to the different tumor types, schedules and doses, the PFS was not analyzed.
Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21, 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose (28-day cycles)	Fridericia-corrected QT (QTcF) interval corrected for heart rate was assessed using triplicate 12-lead electrocardiograms (ECGs). Change in QT interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day-1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing ECG assessment on or prior to Day 1, 0.5 hours prior to dose from assessment on Day 2 and Day 22. The outlying QTcF intervals were defined using the criteria: change from baseline in mean QTcF interval \>30 milliseconds
Percentage of Participants With Changes in R-R Interval From Baseline	Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21: 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose	Changes in R-R interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day -1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing electrocardiogram (ECG) assessment on or prior to Day 1 and 0.5 hours prior to dose for Day 2 and Day 22. Percentage of participants with changes in R-R interval from baseline was calculated as the number of participants with a change not equal to 0 across all time points divided by the number of treated participants multiplied by 100.
Pharmacokinetics: Minimum Plasma Concentration (Cmin)	Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7, 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle	Cmin for LY2334737 and its metabolite 2'2'-difluorodeoxycytidine (dFdC).
Number of Participants With Best Overall Response (BOR)	Baseline to measured disease progression up to 33 weeks	Response defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial Response defined as ≥30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) defined as ≥20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions, or appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease was defined as small changes that did not meet above criteria and unknown defined as response status was not known. The BOR was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).

Other

Measure	Time frame	Description
Number of Participants With Dose-Limiting Toxicity (DLT)	Cycle 1 (28-day cycle)	DLT was defined as an adverse event (AE) during Cycle 1 that was likely related to the LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥ Grade 2 bleeding or Grade 4 thrombocytopenia; with or without bleeding A recovery period longer than 14 days from the last dose of LY2334737 to values allowing Cycle 2 to start; other significant drug-related toxicity deemed by the investigator to be dose limiting or that caused the participant to withdraw from the study.

Countries

France, Germany, United States

Participant flow

Pre-assignment details

Participant Flow is reporting discontinuation from study drug. Completed participants were all those who completed Cycle 1.

Participants by arm

Arm	Count
40 mg LY - Arm A Dose Escalation 40 milligrams (mg) LY2334737 (LY) administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
50 mg LY - Arm A Dose Escalation 50 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
60 mg LY - Arm A Dose Escalation 60 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
70 mg LY - Arm A Dose Escalation 70 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28 -ay treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
80 mg LY - Arm A Dose Escalation 80 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
90 mg LY - Arm A Dose Escalation 90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	5
100 mg LY - Arm A Dose Escalation 100 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	9
40 mg LY - Arm B Dose Escalation 40 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
50 mg LY - Arm B Dose Escalation 50 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
60 mg LY - Arm B Dose Escalation 60 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	7
70 mg LY - Arm B Dose Escalation 70 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	3
80 mg LY - Arm B Dose Escalation 80 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	9
90 mg LY - Arm B Dose Escalation 90 mg LY2334737 administered orally every day for 7 days followed by 7 days without study drug then repeated (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	7
90 mg LY2334737 - Arm A Dose Confirmation 90 mg LY2334737 administered orally every other day for 21 days followed by 7 days without study drug (28-day treatment cycle). Participants could have received additional treatment cycles until discontinuation criterion was met.	12
Total	73

Withdrawals & dropouts

Period	Reason	FG001	FG005	FG006	FG009	FG011	FG012	FG013
Overall Study	Adverse Event	0	1	0	1	3	1	1
Overall Study	Death	0	0	1	0	0	0	1
Overall Study	Investigator Decision	0	0	1	0	1	0	0
Overall Study	Progressive Disease	1	1	1	2	1	2	1
Overall Study	Withdrawal by Subject	0	0	2	0	0	1	0

Baseline characteristics

Characteristic	50 mg LY - Arm B Dose Escalation	60 mg LY - Arm B Dose Escalation	70 mg LY - Arm B Dose Escalation	80 mg LY - Arm B Dose Escalation	90 mg LY - Arm B Dose Escalation	90 mg LY2334737 - Arm A Dose Confirmation	Total	40 mg LY - Arm A Dose Escalation	50 mg LY - Arm A Dose Escalation	60 mg LY - Arm A Dose Escalation	70 mg LY - Arm A Dose Escalation	80 mg LY - Arm A Dose Escalation	90 mg LY - Arm A Dose Escalation	100 mg LY - Arm A Dose Escalation	40 mg LY - Arm B Dose Escalation
Age, Continuous	65.0 years STANDARD_DEVIATION 5	60.1 years STANDARD_DEVIATION 9.3	52.7 years STANDARD_DEVIATION 20	66.0 years STANDARD_DEVIATION 4.6	61.9 years STANDARD_DEVIATION 9.8	63.0 years STANDARD_DEVIATION 6.4	59.9 years STANDARD_DEVIATION 10.4	57.7 years STANDARD_DEVIATION 3.8	60.0 years STANDARD_DEVIATION 20.3	56.3 years STANDARD_DEVIATION 11.2	49.7 years STANDARD_DEVIATION 17.2	49.7 years STANDARD_DEVIATION 9.6	68.2 years STANDARD_DEVIATION 6.2	54.4 years STANDARD_DEVIATION 11.1	55.7 years STANDARD_DEVIATION 7.2
Country of Enrollment France	3 Participants	4 Participants	2 Participants	4 Participants	1 Participants	6 Participants	41 Participants	3 Participants	3 Participants	3 Participants	2 Participants	1 Participants	2 Participants	5 Participants	2 Participants
Country of Enrollment Germany	0 Participants	2 Participants	0 Participants	4 Participants	3 Participants	2 Participants	21 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	3 Participants	3 Participants	1 Participants
Country of Enrollment United States	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants	4 Participants	11 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Disease Stage Stage III	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	6 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Disease Stage Stage IV	3 Participants	6 Participants	3 Participants	9 Participants	7 Participants	9 Participants	67 Participants	3 Participants	3 Participants	2 Participants	3 Participants	3 Participants	4 Participants	9 Participants	3 Participants
Eastern Cooperative Oncology Group (ECOG) 0	3 Participants	4 Participants	1 Participants	5 Participants	2 Participants	7 Participants	43 Participants	3 Participants	2 Participants	3 Participants	3 Participants	1 Participants	3 Participants	4 Participants	2 Participants
Eastern Cooperative Oncology Group (ECOG) 1	0 Participants	3 Participants	2 Participants	3 Participants	5 Participants	5 Participants	29 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants	5 Participants	1 Participants
Eastern Cooperative Oncology Group (ECOG) 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race African	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Race Caucasian	2 Participants	7 Participants	2 Participants	9 Participants	7 Participants	11 Participants	66 Participants	3 Participants	2 Participants	1 Participants	3 Participants	3 Participants	5 Participants	8 Participants	3 Participants
Race Hispanic	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race West Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	0 Participants	1 Participants	1 Participants	6 Participants	4 Participants	4 Participants	25 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	3 Participants	1 Participants
Sex: Female, Male Male	3 Participants	6 Participants	2 Participants	3 Participants	3 Participants	8 Participants	48 Participants	2 Participants	3 Participants	2 Participants	2 Participants	3 Participants	3 Participants	6 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	3 / 3	3 / 3	3 / 3	3 / 3	3 / 3	5 / 5	9 / 9	3 / 3	3 / 3	7 / 7	3 / 3	9 / 9	6 / 7	12 / 12
serious Total, serious adverse events	2 / 3	1 / 3	1 / 3	1 / 3	1 / 3	5 / 5	5 / 9	1 / 3	1 / 3	2 / 7	2 / 3	5 / 9	6 / 7	6 / 12

Outcome results

Primary

Recommended Dose for Phase 2 Studies

Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which \<2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.

Time frame: Baseline up to 28 days postdose in Cycle 1 (28-day cycle)

Population: All participants who received at least 1 dose of study drug during dose escalation and dose confirmation treatment arms.

Arm	Measure	Value (NUMBER)
LY2334737	Recommended Dose for Phase 2 Studies	90 mg every other day for 21 days

Secondary

Number of Participants With Best Overall Response (BOR)

Response defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial Response defined as ≥30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) defined as ≥20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions, or appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease was defined as small changes that did not meet above criteria and unknown defined as response status was not known. The BOR was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).

Time frame: Baseline to measured disease progression up to 33 weeks

Population: All participants who received at least 1 dose of study drug.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
LY2334737	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
LY2334737	Number of Participants With Best Overall Response (BOR)	Progressive Disease	2 Participants
LY2334737	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
LY2334737	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
LY2334737	Number of Participants With Best Overall Response (BOR)	Stable Disease	1 Participants
50 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
50 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
50 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
50 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	2 Participants
50 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	1 Participants
60 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
60 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
60 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	1 Participants
60 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
60 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	2 Participants
70 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	3 Participants
70 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
70 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	0 Participants
70 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
70 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
80 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
80 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	1 Participants
80 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	2 Participants
80 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
80 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Stable Disease	0 Participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	2 Participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Unknown	3 Participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
100 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	4 Participants
100 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
100 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	1 Participants
100 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	4 Participants
100 mg LY - Arm A Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
40 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	0 Participants
40 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	3 Participants
40 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
40 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
40 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
50 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
50 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	2 Participants
50 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
50 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	1 Participants
50 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
60 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
60 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
60 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	2 Participants
60 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	2 Participants
60 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	3 Participants
70 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
70 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	2 Participants
70 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
70 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	1 Participants
70 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	0 Participants
80 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
80 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
80 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	0 Participants
80 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	6 Participants
80 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	3 Participants
90 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Stable Disease	0 Participants
90 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
90 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
90 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	4 Participants
90 mg LY - Arm B Dose Escalation	Number of Participants With Best Overall Response (BOR)	Unknown	3 Participants
90 mg LY - Arm A Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Progressive Disease	10 Participants
90 mg LY - Arm A Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Unknown	2 Participants
90 mg LY - Arm A Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Complete Response	0 Participants
90 mg LY - Arm A Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Partial Response	0 Participants
90 mg LY - Arm A Dose Confirmation	Number of Participants With Best Overall Response (BOR)	Stable Disease	0 Participants

Secondary

Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline

Fridericia-corrected QT (QTcF) interval corrected for heart rate was assessed using triplicate 12-lead electrocardiograms (ECGs). Change in QT interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day-1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing ECG assessment on or prior to Day 1, 0.5 hours prior to dose from assessment on Day 2 and Day 22. The outlying QTcF intervals were defined using the criteria: change from baseline in mean QTcF interval \>30 milliseconds

Time frame: Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21, 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose (28-day cycles)

Population: All participants who received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
LY2334737	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	33.3 percentage of participants
50 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	33.3 percentage of participants
60 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
70 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
80 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
100 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
40 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
50 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
60 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
70 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
80 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	11.1 percentage of participants
90 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants
90 mg LY - Arm A Dose Confirmation	Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline	0.0 percentage of participants

Secondary

Percentage of Participants With Changes in R-R Interval From Baseline

Changes in R-R interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day -1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing electrocardiogram (ECG) assessment on or prior to Day 1 and 0.5 hours prior to dose for Day 2 and Day 22. Percentage of participants with changes in R-R interval from baseline was calculated as the number of participants with a change not equal to 0 across all time points divided by the number of treated participants multiplied by 100.

Time frame: Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21: 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose

Population: All participants who received at least 1 dose of study drug with R-R interval data at all time points.

Arm	Measure	Value (NUMBER)
LY2334737	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
50 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
60 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
70 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
80 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
100 mg LY - Arm A Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
40 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
50 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
60 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
70 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
80 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
90 mg LY - Arm B Dose Escalation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants
90 mg LY - Arm A Dose Confirmation	Percentage of Participants With Changes in R-R Interval From Baseline	100.0 percentage of participants

Secondary

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)

AUC over the dosing interval (AUC0-Ƭ) of dFdC (a metabolite of LY2334737) for Arm A (following a single dose of LY2334737) AUC0-Ƭ is 0-48 hours postdose, Arm B (following multiple doses of LY2334737) AUC 0-Ƭ is 0-24 hours postdose and AUC from time 0 to infinity (AUC0-∞).

Time frame: Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours post dose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours post dose of 28-day cycle

Population: All participants who received at least 1 dose of study drug and had AUC 0-Ƭ and AUC 0-∞ values.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	12.1 nanogramshours/milliliter (ngh/mL)	—
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	12.5 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 30
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	12.1 nanogramshours/milliliter (ngh/mL)	—
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	26.6 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 30
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	31.1 nanogramshours/milliliter (ngh/mL)	—
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	30.7 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 54
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	30.8 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 54
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	30.7 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 13
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	35.7 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 18
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	30.7 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 14
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	25.3 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 46
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	53.4 nanogramshours/milliliter (ngh/mL)	—
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	25.4 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 45
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	54.9 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 65
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	54.8 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 65
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	59.6 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 90
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	55.6 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 67
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	59.1 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 15
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	59.4 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 14
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	21.1 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 109
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	21.2 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 108
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	38.6 nanogramshours/milliliter (ngh/mL)	—
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	19.2 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 24
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	27.8 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 37
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	19.3 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 25
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	28.9 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 8
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	27.2 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 15
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	27.2 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 15
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	54.7 nanogramshours/milliliter (ngh/mL)	—
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	52.1 nanogramshours/milliliter (ngh/mL)	—
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	74.8 nanogramshours/milliliter (ngh/mL)	—
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	25.4 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 46
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	45.5 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 102
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	24.9 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 46
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D21 AUC 0-Ƭ	119 nanogramshours/milliliter (ngh/mL)	—
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-Ƭ	46.0 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 28
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)	C1 D1 AUC 0-∞	46.4 nanogramshours/milliliter (ngh/mL)	Geometric Coefficient of Variation 27

Secondary

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)

Daily AUC from time 0 to 24 hours (AUC 0-24) of dFdU (a metabolite of LY2334737) for Arm A (single dose of LY2334737) and Arm B (multiple doses of LY2334737).

Time frame: Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle

Population: All participants who received at least 1 dose of study drug and had AUC0-24 dFdU results.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	4990 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 3
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	22300 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 31
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	7250 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 20
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	21500 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 49
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	8060 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 48
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	24800 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 18
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	10800 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 23
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	26100 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 4
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	21200 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 57
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	9350 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 30
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	28300 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 38
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	11500 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 35
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	10800 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 37
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	29800 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 23
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	6080 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 16
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	29300 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 37
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	7020 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 6
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	32200 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 2
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	35700 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 37
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	8660 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 16
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	37100 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 27
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	9620 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 3
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	9370 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 39
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	35600 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 27
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D 21	39900 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 35
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)	C1 D1	12400 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 11

Secondary

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737

AUC over the dosing interval (AUC0-Ƭ) of LY2334737 for Arm A (single dose) is 0 to 48 hours postdose. AUC0-Ƭ of LY2334737 for Arm B (multiple doses) is 0 to 24 hours postdose and AUC time 0 to infinity (AUC0-∞) for LY2334737.

Time frame: Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle

Population: All participants who received at least 1 dose of study drug and had AUC0-Ƭ and AUC0-∞ values.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	219 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 31
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	188 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 4
LY2334737	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	188 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 4
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	315 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 34
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	364 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 2
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	315 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 34
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	250 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 45
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	250 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 45
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	188 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 76
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	318 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 22
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	225 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 32
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	225 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 32
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	279 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 33
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	279 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 33
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	341 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 76
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	525 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 93
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	469 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 58
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	469 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 58
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	429 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 14
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	429 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 14
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	647 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 47
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	134 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 71
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	227 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 72
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	133 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 70
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	233 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 12
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	154 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 14
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	156 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 15
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	312 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 27
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	445 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 20
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	314 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 27
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	620 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 119
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	440 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 89
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	437 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 89
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	392 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 31
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	232 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 54
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	234 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 54
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-∞	460 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 35
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D1 AUC0-Ƭ	455 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 35
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737	C1 D21, AUC0-Ƭ	580 nanogramshours per milliliter (ngh/mL)	Geometric Coefficient of Variation 31

Secondary

Pharmacokinetics: Maximum Plasma Concentration (Cmax)

Cmax for LY2334737 and its metabolites 2'2'-difluorodeoxycytidine (dFdC) and difluorodeoxyuridine (dFdU).

Time frame: Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle

Population: All participants who received at least 1 dose of study drug and had Cmax values.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LY2334737	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	68.4 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 11
LY2334737	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	53.9 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 40
LY2334737	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	262 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 6
LY2334737	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	3.64 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 19
LY2334737	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	3.39 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 35
LY2334737	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1060 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 25
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	992 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 51
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	8.22 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 4
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	110 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 41
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	4.83 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 60
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	393 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 24
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	62.6 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 79
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	419 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 42
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	3.94 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 180
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	72.4 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 75
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1120 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 18
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	35.7 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 165
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	6.55 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 109
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1330 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 20
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	13.0 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 27
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	11.3 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 33
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	532 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 27
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	91.8 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 96
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	93.1 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 43
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	10.9 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 243
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	118 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 92
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1050 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 52
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	61.5 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 473
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	467 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 23
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	10.4 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 72
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	126 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 71
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	171 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 105
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	16.0 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 77
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1390 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 35
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	10.2 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 80
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	594 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 29
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	564 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 27
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	89.3 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 72
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	147 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 26
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	12.1 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 91
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	10.9 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 76
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1360 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 19
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	48.8 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 102
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1450 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 38
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	305 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 14
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	10.9 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 19
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	46.5 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 33
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	5.81 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 131
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1670 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 6
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	369 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 13
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	4.05 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 64
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	79.4 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 8
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	10.6 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 26
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	37.9 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 118
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	112 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 37
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	442 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 24
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	106 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 42
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	11.2 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 29
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	6.99 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 39
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1650 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 32
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	9.35 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 69
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	7.03 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 17
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	108 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 51
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	485 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 10
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	134 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 192
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1690 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 29
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	74.4 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 46
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	6.93 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 46
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1680 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 26
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	6.14 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 60
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	466 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 37
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	55.1 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 51
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdU	620 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 11
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-dFdC	16.0 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 43
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D1-LY2334737	163 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 44
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-LY2334737	137 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 62
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdU	1940 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 28
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Maximum Plasma Concentration (Cmax)	C1 D21-dFdC	16.7 nanogram per milliliter (ng/mL)	Geometric Coefficient of Variation 125

Secondary

Pharmacokinetics: Minimum Plasma Concentration (Cmin)

Cmin for LY2334737 and its metabolite 2'2'-difluorodeoxycytidine (dFdC).

Time frame: Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7, 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle

Population: All participants who received at least 1 dose of study drug and had Cmin values

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
LY2334737	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.774 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 52
LY2334737	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	0.431 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 24
LY2334737	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.264 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 34
LY2334737	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.451 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 129
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	1.89 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 28
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.319 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 10
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	0.949 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 47
50 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.223 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 89
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.507 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 47
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.458 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 43
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.519 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 1479
60 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	1.25 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 37
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.279 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 66
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.891 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 45
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	1.01 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 59
70 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	0.612 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 198
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.392 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 15
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.918 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 56
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	1.87 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 155
80 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.568 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 18
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.901 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 94
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	1.04 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 146
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	0.647 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 107
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.901 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 108
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	0.643 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 76
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.920 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 45
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.928 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 179
100 mg LY - Arm A Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.934 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 274
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.379 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 118
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.347 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 148
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	1.21 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 170
40 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	1.45 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 49
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.567 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 53
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.279 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 98
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.523 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 43
50 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	0.409 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 82
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	1.19 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 112
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	1.10 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 60
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	1.50 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 66
60 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.456 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 36
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.347 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 251
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.840 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 133
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.773 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 57
70 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	0.804 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 363
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	1.49 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 80
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	1.04 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 89
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.665 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 80
80 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	0.809 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 99
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 dFdC	1.65 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 134
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 dFdC	2.96 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 180
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D1 LY	0.898 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 84
90 mg LY - Arm B Dose Escalation	Pharmacokinetics: Minimum Plasma Concentration (Cmin)	C1 D21 LY	0.561 nanograms per milliliter (ng/mL)	Geometric Coefficient of Variation 395

Secondary

Progression-Free Survival (PFS)

PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Due to the different tumor types, schedules and doses, the PFS was not analyzed.

Time frame: Baseline to measured disease progression or death up to 33 weeks

Population: Zero participants analyzed. No data collected for PFS.

Other Pre-specified

Number of Participants With Dose-Limiting Toxicity (DLT)

DLT was defined as an adverse event (AE) during Cycle 1 that was likely related to the LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥ Grade 2 bleeding or Grade 4 thrombocytopenia; with or without bleeding A recovery period longer than 14 days from the last dose of LY2334737 to values allowing Cycle 2 to start; other significant drug-related toxicity deemed by the investigator to be dose limiting or that caused the participant to withdraw from the study.

Time frame: Cycle 1 (28-day cycle)

Population: All participants who received at least 1 dose of study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
LY2334737	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
50 mg LY - Arm A Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
60 mg LY - Arm A Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
70 mg LY - Arm A Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
80 mg LY - Arm A Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
90 mg LY - Arm A Dose Escalation and Dose Confirmation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
100 mg LY - Arm A Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	3 Participants
40 mg LY - Arm B Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
50 mg LY - Arm B Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
60 mg LY - Arm B Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	1 Participants
70 mg LY - Arm B Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	0 Participants
80 mg LY - Arm B Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	1 Participants
90 mg LY - Arm B Dose Escalation	Number of Participants With Dose-Limiting Toxicity (DLT)	2 Participants
90 mg LY - Arm A Dose Confirmation	Number of Participants With Dose-Limiting Toxicity (DLT)	1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread

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Brief summary

Detailed description

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Study design

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Primary

Secondary

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Participant flow

Pre-assignment details

Participants by arm

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Baseline characteristics

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Recommended Dose for Phase 2 Studies

Number of Participants With Best Overall Response (BOR)

Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline

Percentage of Participants With Changes in R-R Interval From Baseline

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737

Pharmacokinetics: Maximum Plasma Concentration (Cmax)

Pharmacokinetics: Minimum Plasma Concentration (Cmin)

Progression-Free Survival (PFS)

Number of Participants With Dose-Limiting Toxicity (DLT)