A Study of LY2584702 in Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01241461
First received: November 12, 2010
Last updated: November 17, 2011
Last verified: November 2011

November 12, 2010
November 17, 2011
November 2010
November 2011   (final data collection date for primary outcome measure)
Number of participants with clinically significant effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01241461 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics, area under the concentration time curve (AUC) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of participants with tumor response. [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of LY2584702 in Solid Tumors
A Phase 1 Study of LY2584702 in Japanese Patients With Solid Tumors

The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: LY2584702

Dose escalation starting at 50 mg. On day 1, subjects will receive a single oral dose. After a two day observation period, subjects will receive oral doses twice daily for a 28 day cycle.

Patients may continue 28 day cycles of twice daily dosing until discontinuation criteria are met.

Experimental: LY2584702
Intervention: Drug: LY2584702
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists.
  • Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria In Solid Tumors(RECIST). Japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and Lilly.
  • Have adequate organ function including:

    • Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L,platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL(transfusions are not allowed prior to enrollment within 2 weeks).
    • Hepatic: Bilirubin less than or equal to 1.5 times upper limit of normal (ULN),alkaline phosphatase (ALP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN, or 5 times ULN for patients with hepatic metastases. Patients with bone metastases may enter with alkaline phosphatase values less than 5 times ULN, as long as other hepatic parameters meet inclusion criteria.
    • Renal: Serum creatinine less than or equal to 1.5 times ULN.
  • Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group scale
  • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy.
  • Have an estimated life expectancy of 12 weeks or greater
  • Are able to swallow capsules

Exclusion Criteria:

  • Have received treatment within 4 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
  • Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study.
  • Prior clinical history of tuberculosis (patient doubt tuberculosis is screening required), and positive test results in hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening required).
  • Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without history of CNS metastasis is not required.
  • Have hematologic malignancies, or lymphoma.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01241461
13871, I3G-JE-JGCC
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP