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A Study for Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01214629
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 Metastatic Cancer Drug: LY2523355 Drug: pegfilgrastim 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 I Study of LY2523355 in Patients With Advanced Cancer

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended dose 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, Days 1, 3 of Cycles 1 and 2 ]
  • 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, Days 1, 3 of Cycles 1 and 2 ]

Estimated Enrollment: 70
Study Start Date: July 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2523355 Drug: LY2523355
Administered intravenously 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 0.125mg/m2.
Experimental: LY2523355 + pegfilgrastim Drug: LY2523355
Administered intravenously 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 4mg/m2.
Drug: pegfilgrastim
6 mg administered subcutaneously on day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received.

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, 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
  • Females who are pregnant or lactating
  • Known hypersensitivity to pegfilgrastim or filgrastim
  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): NCT01214629


Locations
United States, New Mexico
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, United States, 87131
United States, Pennsylvania
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.
Philadelphia, Pennsylvania, United States, 19111
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: NCT01214629     History of Changes
Other Study ID Numbers: 11618
I1Y-MC-JFBA ( 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
Metastatic Cancer
Cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes