A Study of LY2875358 in Participants With Advanced Cancer



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/16/2017
Start Date:April 13, 2010
End Date:October 26, 2016

Use our guide to learn which trials are right for you!

A Phase 1 Study of LY2875358 in Patients With Advanced Cancer

The objective of this study is to determine a recommended Phase 2 dose range of LY2875358
that may be safely administered to participants with advanced cancer. In Part A and Part A2
of this study, escalating doses of LY2875358 as monotherapy and in combination with
erlotinib will be evaluated for safety and tolerability, respectively. Part B is a
dose-confirmation segment for LY2875358 therapy in 5 different types of cancer: nonsquamous
non-small cell lung cancer (NSCLC), castrate resistant prostate cancer (CRPC) with bone
metastases, renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), or uveal melanoma
with liver metastases, and for LY2875358 in combination with trametinib in participants with
uveal melanoma with liver metastases.

Protocol amendment (November, 2013) expanded Part B to study LY2875358 in combination with
trametinib in participants with uveal melanoma with liver metastasis.

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 participants 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 HIV, hepatitis A, B or C

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

- Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of
B or C.

- Patients with active alcohol abuse, as determined by the treating investigator.

- 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.

- Part B Expansion Cohort 1 (CRPC):

1. Increasing use of daily doses of opioid analgesics within 28 days prior to
enrollment in the study.

2. Neuroendocrine prostate cancer.

3. Patients who have a solitary bone metastasis that has been irradiated are not
eligible.

- Part B Expansion Cohort 6 (LY2875358 plus trametinib in participants with uveal
melanoma with liver metastasis): Contra-indications for trametinib
We found this trial at
10
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials