A Dose-Escalation Study for Patients With Advanced Cancer

Lilly

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: pegfilgrastim; Drug: LY2523355

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214642

11619 (Registry Identifier)

I1Y-MC-JFBB (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 the dose confirmation phase (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) or Revised International Working Group Lymphoma Response Criteria
• 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
• Females who are pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 4 patient groups

LY2523355 Days 1, 5, 9

Experimental group

Description:

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.

Treatment:

Drug: LY2523355

LY2523355 Days 1, 8

Experimental group

Description:

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.

Treatment:

Drug: LY2523355

LY2523355 Days 1, 5 + pegfilgrastim

Experimental group

Description:

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.

Treatment:

Drug: pegfilgrastim

Drug: LY2523355

LY2523355 Days 1, 4 + pegfilgrastim

Experimental group

Description:

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.

Treatment:

Drug: pegfilgrastim

Drug: LY2523355