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A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer


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

Thank you

Trial Information

A Phase 1 Study of LY3007113, a p38 MAPK Inhibitor, in Patients With Advanced Cancer


Inclusion Criteria:



- Have histological or cytological evidence of a diagnosis of cancer that is advanced
and/or metastatic for which available standard therapies have failed to provide
clinical benefit for their disease

- For Dose Escalation (Part A): cancer, either a solid tumor or a lymphoma

- For Dose Confirmation (Part B): cancer, either a solid tumor or a lymphoma

- Have the presence of measureable or non-measureable disease (Part A) or measureable
disease (Part B) as defined by the Response Evaluation Criteria in Solid Tumors or
the Revised Response Criteria for Malignant Lymphoma

- Have adequate hematologic, hepatic and renal function

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

- Have discontinued all previous therapies for cancer (including chemotherapy,
radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or
14 days for nonmyelosuppressive agents

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

- Are able to swallow capsules

Exclusion Criteria:

- Have an echocardiogram with clinically significant abnormalities

- For Dose Escalation (Part A): Have central nervous system malignancy or metastasis

- For Dose Confirmation (Part B): Have symptomatic central nervous system malignancy
or metastasis

- Have an acute leukemia

- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma
in-situ of the cervix), unless in complete remission and stopped all therapy for that
disease for a minimum of 3 years

- Have received an autologous or allogeneic stem-cell transplant within 75 days of the
initial dose of study drug

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with clinically significant adverse events (AEs) (physical assessments and clinical lab tests)

Outcome Time Frame:

Baseline through study completion (approximately 35 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:

13513

NCT ID:

NCT01463631

Start Date:

December 2011

Completion Date:

November 2013

Related Keywords:

  • Metastatic 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.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