A Study for Patients With Advanced Cancer - Full Text View

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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study of LY2523355 in Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Pegfilgrastim

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Baseline, Days 1, 3 of Cycles 1 and 2 ] [ Designated as safety issue: No ]
Number of participants with tumor response [ Time Frame: Baseline to measured disease progression or discontinuation ] [ Designated as safety issue: No ]
Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Baseline, Days 1, 3 of Cycles 1 and 2 ] [ Designated as safety issue: No ]

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01214629 History of Changes
Other Study ID Numbers:	11618, I1Y-MC-JFBA
Study First Received:	October 1, 2010
Last Updated:	July 13, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Advanced Cancer
Metastatic Cancer
Cancer

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013