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A Phase 1 Study of LY2801653 in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

A Phase 1 Study of LY2801653 in Patients With Advanced Cancer


Inclusion Criteria:



- Part A- Diagnosed with advanced and/or metastatic cancer during dose escalation

- Part B- Diagnosed with adenocarcinoma of the colon or rectum, head and neck squamous
cell carcinoma, or cholangiocarcinoma

- Must be at least 18 years of age

- Adequate hematologic, renal, and liver functions

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

- Ability to swallow capsules, with the exception of head and neck squamous cell
carcinoma participants who may have study drug crushed and administered through a
feeding tube

Exclusion Criteria:

- Have serious preexisting medical conditions that would preclude participation in the
study

- Have a chronic underlying infection

- Have symptomatic central nervous system (CNS) malignancy or metastasis

- Have current acute or chronic leukemia

- Are pregnant or lactating

- Have hepatocellular cancer, liver cirrhosis with a Child-Pugh stage of B or higher,
or have received a liver transplant

- Have a history of congestive heart failure with a New York Heart Association class
greater than 2, unstable angina, recent myocardial infarction (within 6 months of
study enrollment), transient ischemic attacks, stroke, or arterial or venous vascular
disease

- Have a QTc interval greater than 470 msec

- For participants in Part B, a tumor tissue sample is mandatory for biomarker analysis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, 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 (estimated as 3 months)

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-817-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13008

NCT ID:

NCT01285037

Start Date:

November 2009

Completion Date:

October 2015

Related Keywords:

  • Cancer

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.Dunmore, Pennsylvania  18512
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.Washington, District of Columbia  20007