LY2523355 administered intravenously on Days 1, 5 and 9, starting dose is 2 milligrams per meter squared (mg/m\^2) for 2 planned 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.

LY2523355 administered intravenously on Days 1 and 8, starting dose is 8 mg/m\^2 for 2 planned 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.

LY2523355 administered intravenously on Days 1 and 5, starting dose is 8 mg/m\^2 for 2 planned 21-day cycles and 6 mg pegfilgrastim administered subcutaneously on Day 6 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.

LY2523355 administered on Days 1 and 4, starting dose is 12 mg/m\^2 for 2 planned 21-day cycles and 6 mg pegfilgrastim administered subcutaneously on Day 5 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.

pegfilgrastim

LY2523355

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)

This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).

This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in patients with advanced and/or metastatic cancer (including non-Hodgkin's lymphoma) for whom no treatment of higher priority exists.

A Dose-Escalation Study for Patients With Advanced Cancer

A Phase 1 Dose-Escalation Study of LY2523355 in Patients With Advanced Cancer

The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of \>5 days duration, excluding thrombocytopenia; febrile neutropenia.

Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious AEs is located in the Reported Adverse Events module.

Plasma Cmax following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).

Plasma Cmax following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).

Plasma AUC from time zero to infinity \[AUC(0-∞)\] and AUC from time zero to 24 hours post-dose \[AUC(0-24)\] following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).

Plasma AUC from time zero to infinity (0-∞) and AUC from time zero to 24 hours (0-24) post-dose following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).

Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and the Revised International Working Group (IWG) lymphoma response criteria for lymphoma patients. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Tumor response is CR + PR.

Eli Lilly and Company

Part A (Dose Escalation Phase): 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

Part A - Days 1, 5, 9 - 2 mg/m^2/Day

Part A (Dose Escalation Phase): 4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

Part A - Days 1, 5, 9 - 4 mg/m^2/Day

Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

Part A - Days 1, 5, 9 - 8 mg/m^2/Day

Part A (Dose Escalation Phase): 7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

Part A - Days 1, 5, 9 - 7 mg/m^2/Day

Part A (Dose Escalation Phase): 6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

Part A - Days 1, 5, 9 - 6 mg/m^2/Day

Part A (Dose Escalation Phase): 5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

Part A - Days 1, 5, 9 - 5 mg/m^2/Day

Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.

Part A - Days 1, 8 - 8 mg/m^2/Day

Part A (Dose Escalation Phase): 8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.

Part A - Days 1, 5+PEG - 8 mg/m^2/Day

Part A (Dose Escalation Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.

Part A - Days 1, 5+PEG - 12 mg/m^2/Day

Part A (Dose Escalation Phase): 16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.

Part A - Days 1, 5+PEG - 16 mg/m^2/Day

Part A (Dose Escalation Phase): 14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.

Part A - Days 1, 5+PEG - 14 mg/m^2/Day

Part B (Dose Maintenance Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.

Part B - Days 1, 5+PEG - 12 mg/m^2/Day

Part B (Dose Maintenance Phase): 12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously Day 5.

Part B - Days 1, 4+PEG - 12 mg/m^2/d

2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

4 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

7 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

6 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

5 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5, and 9 of 21-day cycle.

8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 of 21-day cycle.

8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus pegfilgrastim (PEG) administered subcutaneously on Day 6.

12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 in Part A and Part B.

Part A and B - Days 1, 5+PEG - 12 mg/m^2/Day

16 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.

14 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.

12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.

Part B - Days 1, 4+PEG - 12 mg/m^2/Day

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

United States

Region of Enrollment

All participants who received at least 1 dose of LY2523355.

Chief Medical Officer

Escalating doses starting at 2 milligrams per meter squared per day (mg/m\^2/day) LY2523355 administered by intravenous infusion over 1 hour on Days 1, 5, and 9; escalating doses starting at 8 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 8 or Days 1 and 5 plus 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6; or 12 mg/m\^2/day LY2523355 administered by intravenous infusion over 1 hour on Days 1 and 4 plus 6 mg PEG administered subcutaneously on Day 5 of 21-day cycle for 2 planned cycles and any subsequent cycle up to 38 cycles of 21-days. The maximum allowed dose was 30 mg/m\^2/day.

LY2523355 / LY2523355 +PEG

Recommended Dose and Schedule for Phase 2 Studies

Serious AEs

Other Non-Serious AEs

Part A - Days 1, 5+PEG - 8 mg/m2/Day

12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6.

All participants who had at least 1 dose of LY2523355.

Number of Participants With Clinically Significant Effects

2 mg/m^2/Day LY2523355

4 mg/m^2/Day LY2523355

5 mg/m^2/Day LY2523355

6 mg/m^2/Day LY2523355

7 mg/m^2/Day LY2523355

8 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion across all schedules and in the presence or absence of PEG administered subcutaneously.

8 mg/m^2/Day LY2523355

12 mg/m\^2/day LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5 of 21-day cycle plus PEG administered subcutaneously on Day 6 and on Days 1 and 4 of 21-day cycle plus PEG administered subcutaneously on Day 5.

12 mg/m^2/Day LY2523355

14 mg/m^2/Day LY2523355

16 mg/m^2/Day LY2523355

All participants who received 1 dose of LY2523355 and had Cmax samples collected on Day 1 of Cycle 1.

Pharmacokinetics Maximum Concentration (Cmax), Single Dose

All participants who received 2 doses of study drug and had a Cmax sample collected on Days 4, 5, 8 or 9 of Cycle 1 (based on schedule of administration) after multiple dose administration of LY2523355.

Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose

AUC(0-∞)

AUC(0-24)

5 mg/m^2/Day LY25233552

All participants who received 1 dose of LY2523355 and had pharmacokinetic samples collected on Day 1 of Cycle 1 to enable calculation of AUC(0-∞) and AUC(0-24).

Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose

All participants who received 2 doses of study drug and had pharmacokinetic samples collected on Day 4, 5, 8, or 9 of Cycle 1 (based on schedule of administration) to enable calculation of AUC(0-∞) and AUC(0-24) after multiple dose administration of LY2523355.

Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose

Escalating dose started at 2 milligrams per meter squared (mg/m\^2) LY2523355 administered intravenously as a 1-hour infusion on Days 1, 5 and 9, for two planned cycles of 21 days. Dose could be escalated by a maximum increment of the lesser of doubling the current dose or 4 milligrams per meter squared per day (mg/m\^2/day), with a maximum allowed dose of 30 mg/m\^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21 days.

LY2523355 Days 1, 5 and 9

Escalating dose started at 8 mg/m\^2 of LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 8 for two planned 21-day cycles. Dose could be escalated by a maximum of 4 mg/m\^2/day, with a maximum allowed dose of 30 mg/m\^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.

LY2523355 Days 1 and 8

Escalating dose started at 8 mg/m\^2 LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 5, for two planned cycles of 21-days and 6 mg pegfilgrastim (PEG) administered subcutaneously on Day 6 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Dose could be escalated by a maximum of 4 mg/m\^2/day, with a maximum allowed dose of 30 mg/m\^2/day. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.

LY2523355 Days 1 and 5 + PEG

12 mg/m\^2 LY2523355 administered intravenously as a 1-hour infusion on Days 1 and 4, for two planned 21 days cycles, 6 mg PEG administered subcutaneously on Day 5 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received. Participants continued on study drug until disease progression, unacceptable toxicity or other withdrawal criterion were met up to 38 cycles of 21-days.

LY2523355 Days 1 and 4 + PEG

All participants who received 1 dose of LY2523355.

Number of Participants With Tumor Response

Part A and B- Days 1, 5+PEG - 12 mg/m^2/Day

Overall Study

Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 alone arm is 0.125 milligrams per meter square per day (mg/m²/day).

Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 + pegfilgrastim is 4 mg/m²/day.

6 milligrams (mg) administered subcutaneously on Day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received.

This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in participants with advanced and/or metastatic cancer (including Non-Hodgkin's Lymphoma) for whom no treatment of higher priority exists.

A Study for Participants With Advanced Cancer

A Phase I Study of LY2523355 in Patients With Advanced Cancer

Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused \<1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of \>5 days duration; any febrile neutropenia.

Adverse events (AEs) were considered clinically significant effects. Data presented are the number of participants who experienced serious AEs (SAEs), other non-serious AEs and deaths during the study, including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Cmax following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

Cmax following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

AUC(0-∞) following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

AUC(0-∞) following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.

Data presented are the number of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions.

0.125 mg/m²/day LY2523355 (LY) was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

0.125 mg/m²/Day LY

0.25 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

0.25 mg/m²/Day LY

0.5 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

0.5 mg/m²/Day LY

1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

1.0 mg/m²/Day LY

2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

2.0 mg/m²/Day LY

4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

4.0 mg/m²/Day LY

4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.

6 milligrams (mg) pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.

Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

4.0 mg/m²/Day LY + 6 mg PEG

5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

5.0 mg/m²/Day LY

6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

6.0 mg/m²/Day LY

6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.

6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.

Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

6.0 mg/m²/Day LY + 6 mg PEG

7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.

6 mg pegfilgrastim was administered SC on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.

Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.

7.0 mg/m²/Day LY + 6 mg PEG

0.125 milligrams per meter square per day (mg/m²/day) LY2523355 (LY) was administered as an intravenous (IV) infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until progressive disease (PD), unacceptable toxicity or other withdrawal criterion is met

2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met

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

0.125 to 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle)

4.0 to 7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day Cycle).

LY2523355 + Pegfilgrastim

Recommended Dose for Phase 2 Studies

SAEs

Death

4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles.

6 mg pegfilgrastim (PEG) was administered subcutaneously (SC) on Day 4 of each 21-day cycle for at least 2 cycles and for any subsequent cycles of LY2523355 received.

Participants could continue on study drug until PD unacceptable toxicity or other withdrawal criterion is met.

1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).

2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).

4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).

5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).

6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).

7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Day 1 of Cycle 1 (21-day cycle).

7.0 mg/m²/Day LY

All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1 of Cycle 1.

Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose

1.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle).

2.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle).

4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle) or 4.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day cycle).

5.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle).

6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 of Cycle 1 (21-day cycle) or 6.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day cycle).

7.0 mg/m²/day LY2523355 was administered as an IV infusion over 1 hour on Days 1, 2 and 3 with 6 mg pegfilgrastim administered SC on Day 4 of Cycle 1 (21-day cycle).

All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable determination of the LY2523355 Cmax on Day 3 of Cycle 1.

Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses

All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 1 of Cycle 1.

Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose

All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 3 of Cycle 1.

Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses

0.125 milligrams per meter square per day (mg/m²/day) LY2523355 (LY) was administered as an intravenous (IV) infusion over 1 hour on Days 1, 2 and 3 of each 21-day cycle for at least 2 cycles. Participants could continue on study drug until progressive disease (PD), unacceptable toxicity or other withdrawal criterion is met.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose-Escalation Study for Patients With Advanced Cancer	NCT01214642	Advanced Cancer	pegfilgrastim LY2523355	18 Years -	Eli Lilly and Company
A Study for Participants With Advanced Cancer	NCT01214629	Advanced Cancer Metastatic Canc...	LY2523355 LY2523355 pegfilgrastim	18 Years -	Eli Lilly and Company
A Study for Participants With Advanced Cancer	NCT01214629	Advanced Cancer Metastatic Canc...	LY2523355 LY2523355 pegfilgrastim	18 Years -	Eli Lilly and Company
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck	NCT01059643	Ovarian Cancer Non Small Cell ... Prostate Cancer Colorectal Canc... Gastric Cancer Esophageal Canc... Cancer of Head ...	LY2523355 pegfilgrastim	18 Years -	Eli Lilly and Company
A Study for Patients With Acute Leukemia	NCT01214655	Acute Leukemia	LY2523355	18 Years -	Eli Lilly and Company
A Study for Patients With Acute Leukemia	NCT01214655	Acute Leukemia	LY2523355	18 Years -	Eli Lilly and Company
A Study of LY2523355 in Patients With Solid Cancer	NCT01358019	Solid Tumors	LY2523355	20 Years -	Kyowa Kirin Co., Ltd.
A Study for Participants With Advanced Cancer	NCT01214629	Advanced Cancer Metastatic Canc...	LY2523355 LY2523355 pegfilgrastim	18 Years -	Eli Lilly and Company
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck	NCT01059643	Ovarian Cancer Non Small Cell ... Prostate Cancer Colorectal Canc... Gastric Cancer Esophageal Canc... Cancer of Head ...	LY2523355 pegfilgrastim	18 Years -	Eli Lilly and Company
A Study of LY2523355 in Participants With Breast Cancer	NCT01416389	Metastatic Brea...	LY2523355 ixabepilone pegfilgrastim filgrastim	18 Years -	Eli Lilly and Company
A Study of LY2523355 in Participants With Breast Cancer	NCT01416389	Metastatic Brea...	LY2523355 ixabepilone pegfilgrastim filgrastim	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for ly2523355

Every month we try and update this database with for ly2523355 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ly2523355

Every month we try and update this database with for ly2523355 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ly2523355 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.