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A Phase 1 Study of LY2624587 in Patients With Advanced Cancer


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

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Trial Information

A Phase 1 Study of LY2624587 in Patients With Advanced Cancer


Inclusion Criteria:



- Present with histological or cytological evidence of a diagnosis of cancer (solid
tumors, lymphoma, or chronic lymphocytic leukemia) that is advanced and/or
metastatic. The patient must be, in the judgement of the investigator, an
appropriate candidate for experimental therapy after available standard therapies
have been used.

- Have the presence of measurable or nonmeasurable disease as defined by Response
Evaluation Criteria in Solid Tumors (RECIST), Revised International Working Group
Lymphoma Response Criteria, or National Cancer Institute Working Group Guidelines for
Chronic Lymphocytic Leukemia.

- Have adequate organ function.

- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group
(ECOG) scale.

- 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 serum pregnancy test
less than or equal to 7 days prior to the first dose of study drug.

- Have discontinued chemotherapy and cancer-related hormonal therapy with
commercially-available agents for at least 21 days (6 weeks for mitomycin-C or
nitrosoureas) and radiotherapy for at least 14 days prior to study enrollment and
recovered from the acute effects of therapy (less than or equal to National Cancer
Institute's Common Terminology Criteria for Adverse Events (CTCAE v 4.02; Grade 1).
Hormone refractory prostate cancer patients receiving gonadotropin releasing hormone
(GnRH) agonist therapy or breast cancer patients on anti-estrogen therapy (for
example, an aromatase inhibitor) prior to entrance on the study may have that
treatment continued while they are enrolled in Study CXBA.

- Have an estimated life expectancy of greater than or equal to 12 weeks.

Exclusion Criteria:

- Have received treatment with an investigational drug, which has not received
regulatory approval for any indication, within 28 days of study treatment with
LY2624587.

- Have medical conditions that, in the opinion of the investigator, would preclude
participation in this study.

- Have symptomatic central nervous system malignancy or metastasis. Patients 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 patients without history of CNS metastases
is not required.

- Have a history of major organ transplant.

- Have current acute leukemia.

- Have active human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C
antibodies.

- Have QTc greater than 470 msec (female) or greater than450 msec (male), history of
congenital long QT syndrome or other conduction abnormality.

- Have had an autologous or allogenic bone marrow transplant.

- Previously treated with a CXCR4 antagonist, or have had a significant allergy to
biologic agents.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose 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 hour EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13740

NCT ID:

NCT01139788

Start Date:

June 2010

Completion Date:

November 2011

Related Keywords:

  • Metastatic Cancer
  • Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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. Phoenix, Arizona  85012
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