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A Phase 1 Dose-Escalation Study of LY2523355 in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

Thank you

Trial Information

A Phase 1 Dose-Escalation Study of LY2523355 in Patients With Advanced Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose and schedule for Phase 2 studies

Outcome Time Frame:

Baseline to study completion

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

11619

NCT ID:

NCT01214642

Start Date:

May 2008

Completion Date:

June 2012

Related Keywords:

  • Advanced Cancer
  • Advanced Cancer
  • Cancer
  • Neoplasms

Name

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.Memphis, Tennessee  38138
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.Bedford, Texas  76022