Neoplasms

Symptoms and General Pathology

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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).

LY2523355

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.

pegfilgrastim

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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 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.

Eli Lilly and Company

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

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

United States

Region of Enrollment

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

Chief Medical Officer

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.

Number of Participants With Clinically Significant Effects

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

Number of Participants With Tumor Response

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.

Spots Global Cancer Trial Database for A Study for Participants With Advanced Cancer

Trial Identification

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Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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