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A Phase 1 Study of LY2875358 in Patients With Advanced Cancer


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

Thank you

Trial Information

A Phase 1 Study of LY2875358 in Patients With Advanced Cancer


Inclusion Criteria:



- Part A: Have histological or cytological evidence of cancer (solid tumor, lymphoma,
or multiple myeloma) that is advanced and/or metastatic and an appropriate candidate
for experimental therapy

- Part A2: Histologic or cytologic diagnosis of advanced Non Small Cell Lung Cancer
(NSCLC), Stage IIIB with malignant pleural effusion or Stage IV, completed at least 1
prior systemic regimen, and eligible for erlotinib therapy.

- Part B: Candidate for experimental therapy after standard therapies used or
non-eligible for standard therapies. Histological or cytological evidence of 1 of
the 5 tumor types:

- Castrate-resistant prostate cancer (CRPC) with bone metastasis:

--Progressive Disease in the setting of castrate level of testosterone

- Renal Cell Carcinoma (RCC):

--Histologic diagnosis of either clear-cell or papillary RCC (metastatic and
unresectable, or bilateral, multifocal, unresectable RCC localized to kidneys).

- NSCLC:

--Histologic or cytologic diagnosis of advanced NSCLC, Stage IIIB with malignant
pleural effusion or Stage IV

- Hepatocellular Carcinoma (HCC)

--Histologic or cytologic diagnosis of hepatocellular carcinoma

- Uveal Melanoma with liver metastasis

- Part A: Have the presence of measurable or nonmeasurable disease as defined by the
RECIST v1.1 (Eisenhauer et al. 2009) or Revised Response Criteria for Malignant
Lymphoma (Cheson et al. 2007) or have measureable disease for multiple myeloma.

- Part A2 & B (RCC, NSCLC, HCC, and uveal melanoma): Have measurable disease as
defined by RECIST v1.1.

- Give written informed consent prior to any study-specific procedures.

- Adequate organ function.

- Performance status of less than or equal to 2 on ECOG scale.

- Discontinued all previous cancer therapies, and any agents that have not received
regulatory approval, for at least 21 days and recovered from the acute effects of
therapy. Must have discontinued mitomycin-C or nitrosourea therapy for at least 42
days.

- Reliable and available for the duration of the study and willing to follow study
procedures.

- Males and females (reproductive potential): Use medically approved contraceptive
precautions during the study and for 4 months following the last dose of study drug.

- Females (childbearing potential): Have had a negative serum pregnancy test before
the first dose of study drug and not be breast-feeding.

- Estimated life expectancy that will permit the patient to complete 8 weeks of
treatment.

Exclusion Criteria:

- Serious preexisting medical conditions

- Symptomatic central nervous system malignancy or metastasis (screening not required).

- Acute or chronic leukemia.

- Active infection including

- Have second primary malignancy that may affect the interpretation of results.

- Part A2: Unable to swallow tablets. Intolerant of therapy with erlotinib.
Concomitant treatment with the cytochrome P450 3A (CYP3A) modulators. Must not have
received treatment with any of these modulators within 14 days of study treatment.

- Have a history of New York Heart Association class ≥3, unstable angina, myocardial
infarction 6 months prior to study drug

- QTc greater than 470 msec.

- Received previous treatment with any c-MET experimental therapeutic

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 (3 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:

13298

NCT ID:

NCT01287546

Start Date:

April 2010

Completion Date:

June 2015

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.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.Jacksonville, Florida  32256
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.Athens, Georgia  30607
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.Kalamazoo, Michigan  49048
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.Dunmore, Pennsylvania  18512