A Study for Participants With Advanced Cancer | NCT01214629

NCT01214629

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I1Y-MC-JFBA	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
LY2523355	Experimental		Drug: LY2523355
LY2523355 + pegfilgrastim	Experimental		Drug: LY2523355 Drug: pegfilgrastim

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY2523355	Drug	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recommended Dose for Phase 2 Studies	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.	Baseline, daily up to 21 days in Cycle 1

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Clinically Significant Effects	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. Participants entering Part B of the study must also have a tumor that is safely amenable to serial biopsies
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST, Therasse et al. 2000) or Revised International Working Group Lymphoma Response Criteria (Cheson et al. 2007)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Females with child bearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
Have an estimated life expectancy of greater than or equal to 12 weeks

Exclusion Criteria:

Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastases is not required
Have current acute or chronic leukemia
Have had an autologous or allogenic bone marrow transplant
Have the following conduction abnormalities: PR >250 milliseconds (msec), second degree or complete atrioventricular (AV) block, intraventricular conduction delay (IVCD) with QRS ≥120 msec, left branch bundle block (LBBB), right branch bundle block (RBBB), Wolf-Parkinson- White syndrome (WPW), left anterior fascicular block (LAFB), left posterior fascicular block (LPFB), or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study.
Females who are pregnant or lactating
Known hypersensitivity to pegfilgrastim or filgrastim

Contacts/Locations Module

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Albuquerque	New Mexico	87131

Arm/Group Information

ID	Title	Description
FG000	0.125 mg/m²/Day LY	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.
FG001	0.25 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.
FG002	0.5 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.
FG003	1.0 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.
FG004	2.0 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.
FG005	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. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
FG006	5.0 mg/m²/Day LY	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.
FG007	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. Participants could continue on study drug until PD, unacceptable toxicity or other withdrawal criterion is met.
FG008	4.0 mg/m²/Day LY + 6 mg PEG	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.
FG009	6.0 mg/m²/Day LY + 6 mg PEG	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.
FG010	7.0 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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0001 subjects FG0011 subjects FG0021 subjects FG0033 subjects FG0043 subjects FG00513 subjects FG0065 subjects FG0073 subjects FG0083 subjects FG00918 subjects FG0103 subjects
Received at Least 1 Dose of Study Drug		FG0001 subjects FG0011 subjects FG0021 subjects FG0033 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG004
NOT COMPLETED		FG0001 subjects FG0011 subjects FG0020 subjects FG0032 subjects FG004

Type	Comment	Reasons
Progressive Disease		FG0001 subjects FG0011 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	0.125 mg/m²/Day LY	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

Units	Counts
Participants	BG000

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

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Recommended Dose for Phase 2 Studies

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.

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

Posted

Number

mg/m²/day

Baseline, daily up to 21 days in Cycle 1

ID	Title	Description
OG000	LY2523355

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	0.125 mg/m²/Day LY	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.

ID	Term
D009362	Neoplasm Metastasis
D009369	Neoplasms

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

ID	Term
C000591843	litronesib
C455861	pegfilgrastim