A Dose-Escalation Study for Patients With Advanced Cancer

NCT01214642 | Completed Phase 1 Results

• 2 other identifiers: 11619I1Y-MC-JFBB
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Cancer

Outcome Measures

Primary Outcomes (1)

• Recommended Dose and Schedule for Phase 2 Studies

  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.

  Cycle 1 (21 days): Day 1, 5 and 9, any AE reported

Secondary Outcomes (6)

• Number of Participants With Clinically Significant Effects

  Baseline to Cycle 38 (21-day cycles): daily for AEs

• Pharmacokinetics Maximum Concentration (Cmax), Single Dose

  Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose

• Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose

  Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose

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

  Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose

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

  Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose

Study Arms (4)

LY2523355 Days 1, 5, 9

EXPERIMENTAL

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.

Drug: LY2523355

LY2523355 Days 1, 8

EXPERIMENTAL

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.

Drug: LY2523355

LY2523355 Days 1, 5 + pegfilgrastim

EXPERIMENTAL

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.

Drug: pegfilgrastim; Drug: LY2523355

LY2523355 Days 1, 4 + pegfilgrastim

EXPERIMENTAL

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.

Drug: pegfilgrastim; Drug: LY2523355

Interventions

pegfilgrastim DRUG

Administered subcutaneously

LY2523355 Days 1, 4 + pegfilgrastim; LY2523355 Days 1, 5 + pegfilgrastim

LY2523355 DRUG

Administered intravenously

LY2523355 Days 1, 4 + pegfilgrastim; LY2523355 Days 1, 5 + pegfilgrastim; LY2523355 Days 1, 5, 9; LY2523355 Days 1, 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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.

Nashville, Tennessee, 37203, United States

Location

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.

San Antonio, Texas, 78229-3307, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pegfilgrastim; litronesib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 5, 2010
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: August 6, 2018
• Results First Posted: August 6, 2018

Record last verified: 2018-08

Locations

US (2)