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A Dose-Escalation Study for Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01214642
First Posted: October 5, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
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).

Condition Intervention Phase
Advanced Cancer Drug: pegfilgrastim Drug: LY2523355 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Study of LY2523355 in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended dose and schedule for Phase 2 studies [ Time Frame: Baseline to study completion ]

Secondary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Baseline, Cycle 1 and Cycle 2 at each dose level for all 4 schedules ]
  • Number of participants with tumor response [ Time Frame: Baseline to measured disease progression or discontinuation ]
  • Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Baseline, Cycle 1 and Cycle 2 at each dose level for all 4 schedules ]

Estimated Enrollment: 50
Study Start Date: May 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2523355 1,5,9
LY2523355 administered intravenously on days 1, 5 and 9, starting dose is 2 mg/m^2 for two planned cycles of 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.
Drug: LY2523355
Administered intravenously
Experimental: LY2523355 1,8
LY2523355 administered intravenously on days 1 and 8, starting dose is 8mg/m^2 for two planned 21 day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion are met.
Drug: LY2523355
Administered intravenously
Experimental: LY2523355 1,5 + pegfilgrastim
LY2523355 administered intravenously on days 1 and 5, starting dose is 8mg/m^2 for two planned cycles of 21 days 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
Administered subcutaneously
Drug: LY2523355
Administered intravenously
Experimental: LY2523355 1,4 + pegfilgrastim
LY2523355 administered on days 1 and 4, starting dose is 12 mg/m^2 for two planned 21 days cycles. 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
Administered subcutaneously
Drug: LY2523355
Administered intravenously

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214642


Locations
United States, Tennessee
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, United States, 37203
United States, Texas
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, United States, 78229-3307
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01214642     History of Changes
Other Study ID Numbers: 11619
I1Y-MC-JFBB ( Other Identifier: Eli Lilly and Company )
First Submitted: October 1, 2010
First Posted: October 5, 2010
Last Update Posted: October 12, 2017
Last Verified: July 2012

Keywords provided by Eli Lilly and Company:
Advanced Cancer
Cancer

Additional relevant MeSH terms:
Neoplasms