Know Cancer

forgot password

A Phase 1 Study of LY2875358 in Japanese Patients With Advanced Malignancies

Phase 1
20 Years
Open (Enrolling)
Solid Tumors, Lymphoma, Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Phase 1 Study of LY2875358 in Japanese Patients With Advanced Malignancies

This study has 3 parts. Participants may only enroll in one part.

Part A - Participants will receive LY2875358.

Part B1 - Participants with non-small cell lung cancer (NSCLC) will receive LY2875358 and

Part B2 - Participants with NSCLC will receive LY2875358 and gefitinib.

Parts B1 and B2 were added per protocol amendment in January, 2013.

Inclusion Criteria:

- Part A: Have histological or cytological evidence of malignancies (solid tumor or
lymphoma) that are advanced and/or metastatic. The participant must be, in the
judgment of the investigator, an appropriate candidate for experimental therapy after
available standard therapies have been used

- Part B1: Have histologic or cytologic diagnosis of advanced NSCLC, Stage IV per the
7th edition of the American Joint Committee on Cancer (AJCC) Staging Criteria for
NSCLC. The participants must have no other effective therapeutic option and be
eligible for erlotinib therapy per Japanese package insert in the opinion of

- Part B2: Have histologic or cytologic diagnosis of advanced NSCLC with epidermal
growth factor receptor (EGFR) activating mutation, Stage IV per the 7th edition of
the AJCC Staging Criteria for NSCLC. The participants must have no other effective
therapeutic option and be eligible for gefitinib therapy per Japanese package insert
in the opinion of investigator

- Have the presence of measurable or nonmeasurable disease as defined by the Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Revised Response Criteria
for Malignant Lymphoma

- Have adequate hematologic, hepatic and renal function

- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG)

- Have discontinued all previous cancer therapies, and any agents that have not
received regulatory approval for any indication, for at least 21 days or 5 half lives
prior to study enrollment, whichever is shorter, and recovered from the acute effects
of therapy (treatment-related toxicity resolved to baseline or ≤ Grade 1).
Participants must have discontinued mitomycin-C or nitrosourea therapy for at least
42 days

- Males and females with reproductive potential: Must agree to use medically approved
contraceptive precautions during the study and for 4 months following the last dose
of study drug or until in the judgment of the investigator, it is safe for the
participant to become pregnant

- Females with child bearing potential: Have had a negative urine pregnancy test ≤7
days before the first dose of study drug and must also not be breastfeeding. If
female who stop breastfeeding enter the study, the female must stop breastfeeding
from the day of the first study drug administration until 4 months after the last

- Have an estimated life expectancy, in the judgment of the investigator, that will
permit the participant to complete 8 weeks of treatment

Exclusion Criteria:

- Have serious preexisting medical conditions

- Part A: Have symptomatic central nervous system malignancy or metastasis

- Part B: Have brain metastases that are symptomatic or require ongoing treatment with
steroids or radiation therapy

- Have current acute or chronic leukemia (participants with adult T-cell
leukemia/lymphoma are eligible)

- Have an active fungal, bacterial, and/or known viral infection

- Have a second primary malignancy that in the judgment of the investigator and sponsor
may affect the interpretation of results

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

- Have QTc interval of >470 milliseconds (msec) on screening electrocardiogram

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

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

- Previous treatment with any extracellular domain of mesenchymal-epithelial transition
factor (c-MET) targeting experimental therapeutic (for example, XL184, ARQ197, or

- Have a history of radiation therapy involving more than 25% of the bone marrow.
Previous radiation therapy is allowed but should have been limited and must not have
included whole pelvis radiation

- Part B: The participants actively receiving warfarin therapy at the time of

- Part B: Concomitant treatment with the cytochrome P450 (CYP) 3A4 modulators. The
participants must not have received treatment with any of these modulators within 14
days of Cycle 1 Day 1

- Part B: Have any evidence of clinically active interstitial lung disease (ILD).
Asymptomatic participants with chronic, stable, radiographic changes are eligible

- Part B: Have preexisting interstitial lung disease risks as evidenced by computed
tomography (CT) scan/X-ray at baseline; have or had any disease of acute lung injury,
idiopathic pulmonary fibrosis, pneumonitis, or pneumoconiosis evident on an x-ray;
have or had any disease of radiation pneumonia or drug-induced pneumonia, which
requires treatment with corticosteroids

- Part B: Have previously been intolerant of therapy with erlotinib or gefitinib

Type of Study:


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 one or more drug (or procedure)-related adverse events (AEs) or any serious AEs

Outcome Time Frame:

Baseline up to 56 days after last dose of study drug

Safety Issue:


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


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

June 2012

Completion Date:

May 2014

Related Keywords:

  • Solid Tumors
  • Lymphoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lymphoma