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A Phase 1 Dose-Escalation Study of LY2603618 in Combination With Gemcitabine in Japanese Patients With Solid Tumors

Phase 1
20 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase 1 Dose-Escalation Study of LY2603618 in Combination With Gemcitabine in Japanese Patients With Solid Tumors

Inclusion Criteria:

- Have histological or cytological or imaging evidence of a diagnosis of cancer that is
advanced and/or metastatic disease

- Patient who is planned to have gemcitabine therapy at the proposed doses because
he/she was not able to benefit from standard therapy and/or therapies known to
provide clinical benefit or there is no standard therapy for the advanced and/or
metastatic disease globally

- Have given written informed consent prior to any study-specific procedures

- Have adequate hematologic, hepatic and renal function

- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG)

- Have discontinued all previous therapies for cancer, including
chemotherapy,cancer-related hormonal therapy, or other investigational therapy for at
least 30 days (42 days for mitomycin C or nitrosoureas) prior to study enrollment and
recovered from the acute effects of therapy

- Prior radiation therapy for treatment of cancer is allowed to less than 25% of the
bone marrow, and patients must have recovered from the acute toxic effects of their
treatment prior to study enrollment. Prior radiation to the whole pelvis is not
allowed. Prior radiotherapy must be completed at least 30 days prior to study

- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the study and for 3 months after the last infusion
of study drug

- Females with child bearing potential (not surgically sterilized and between menarche
and 1 year post menopause) must have had a negative urine pregnancy test less than 7
days prior to the enrollment

- Are reliable and willing to make themselves available for the duration of the study
and are willing to follow study procedures

- Have an estimated life expectancy of at least 12 weeks

Exclusion Criteria:

- Are currently enrolled in, or discontinued within the last 30 days from, a clinical
study involving an off-label use of an investigational drug or device (other than the
study drug used in this study), or concurrently enrolled in any other type of medical
research judged not to be scientifically or medically compatible with this study

- Have serious preexisting medical conditions or serious concomitant systemic disorders
that would compromise the safety of the patient or his/her ability to complete the

- Have interstitial pneumonitis or pulmonary fibrosis, or previous history of them

- Have symptomatic central nervous system malignancy or metastasis

- Have current active infection

- Females who are pregnant or lactating

- Have known positive test results in human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBSAg), or hepatitis C antibodies (HCAb)

- Patients with acute or chronic leukemia or with any other disease likely to have a
significant bone marrow infiltration

- Have previously completed or withdrawn from this study or any other study
investigating LY2603618 or any other Chk1 inhibitor

- Have known allergy to gemcitabine or LY2603618 or any ingredient of gemcitabine or
LY2603618 (like Captisol®)

- Have an abnormal ECG result that would put the patient at unnecessary risk in the
opinion of the investigator

Type of Study:


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 effects

Outcome Time Frame:

Baseline to study completion (approximately 12 months)

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:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Solid Tumors
  • Neoplasms