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A Phase 1 Study of an Oral p38 MAPK Inhibitor in Patients With Advanced Cancer


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

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Trial Information

A Phase 1 Study of an Oral p38 MAPK Inhibitor in Patients With Advanced Cancer


Inclusion Criteria:



- Have histological or cytological evidence of a diagnosis of cancer (including
lymphoma) that is advanced or metastatic disease for which no therapy of higher
priority (approved therapies or therapies with published substantial evidence of
effectiveness) is available, or for whom no standard therapy exists

- Have the presence of measurable or nonmeasurable disease as defined by Modified
Response Evaluation Criteria in Solid Tumors (RECIST)

- 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, or other investigational therapy for at least 14 days (42 days for
mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute
effects of therapy

- 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 and/or tablets

Exclusion Criteria:

- Have received treatment within 14 days of the initial dose of study drug with a drug
that has not received regulatory approval for any indication

- Have a history of major surgical resection involving the stomach or small bowel, or
have serious preexisting medical conditions (based on judgment of the investigator)

- Have symptomatic central nervous system malignancy or metastasis (screening is not
required)

- Have a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative
colitis)

- Have an active hematologic malignancy other than lymphoma

- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBSAg), or hepatitis C antibodies (HCAb). Screening at baseline will
not be required for enrollment

- Concurrent administration of any immunosuppressive therapy

- Females who are pregnant or lactating

- Have received, within 7 days of the initial dose of study drug, either grapefruit
juice or treatment with a drug that is a known inhibitor or inducer of Cytochrome
P450 Enzyme 3A4 (CYP3A4). In addition, patients should not receive grapefruit juice
or treatment with a CYP3A4 inhibitor or inducer during the study

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:

Number of participants with clinically significant effects (physical assessments and safety lab tests)

Outcome Time Frame:

Baseline through study completion (approximately 41 months)

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:

12284

NCT ID:

NCT01393990

Start Date:

August 2008

Completion Date:

July 2013

Related Keywords:

  • 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.Minneapolis, Minnesota  55404
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