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A Phase I Study of LY2584702 in Patient With Advanced or Metastatic Cancer


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

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Trial Information

A Phase I Study of LY2584702 in Patient With Advanced or Metastatic Cancer


Inclusion Criteria:



- Have histological or cytological evidence of a diagnosis of advanced and/or
metastatic cancer (solid tumors) that is refractory to standard therapy and/or
therapies known to provide clinical benefit, or for which no standard therapy exists

- Have the presence of disease amenable to efficacy assessment as defined by the
Response Evaluation Criteria in Solid Tumors. Patients who have advanced
non-measurable disease with elevation of a validated tumor marker may be eligible, if
discussed and agreed upon by the investigator and the sponsor

- Patients entering Part C of the study must have a tumor that is safely amenable to 2
biopsies (one pre-treatment and one on-treatment biopsy for the same tumor). Patients
in Part C of the study must agree to biopsy procedures at time of consent

- Have adequate hematologic, renal, and hepatic organ function

- Have a performance status of less than or equal to 2 on the Eastern Cooperative
Oncology Group (ECOG) scale

- Have discontinued all previous therapies for cancer, including chemotherapy,
radiotherapy, cancer-related hormonal therapy (with the exception of continuing
gonadotropic releasing hormone (GnRH) agonist therapy for patients with prostate
cancer, or anti-estrogen therapy [for example, an aromatase inhibitor] for patients
with breast cancer), or other investigational therapy for at least 3 weeks (6 weeks
for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the
acute effects of therapy

- Are reliable and willing to be available for the duration of the study and are
willing to follow study procedures

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

- Are able to swallow capsules

Exclusion Criteria:

- Have received treatment within 3 weeks of the initial dose of study drug with a drug
that has not received regulatory approval for any indication

- Have 1 or more serious preexisting medical conditions that, in the opinion of the
investigator, would preclude participation in this study.

- Have symptomatic central nervous system (CNS) 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 metastasis
is not required

- Have hematologic malignancies, or lymphoma

- Females who are pregnant or lactating

- Have a second primary malignancy that, in the judgment of the investigator and
sponsor, may affect the interpretation of results

- Have bleeding diathesis

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety 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 (approximately 41 months)

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-817-285-4559) or 1-317-615-4559 Mon-Fri 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:

12451

NCT ID:

NCT01394003

Start Date:

November 2008

Completion Date:

April 2011

Related Keywords:

  • Advanced Cancer
  • Advanced 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.Greenbrae, California  94904
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