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
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: LY2584702
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2584702 in Japanese Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2584702 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.


  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241461

Locations
Japan
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.
Chiba, Japan
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01241461     History of Changes
Other Study ID Numbers: 13871, I3G-JE-JGCC
Study First Received: November 12, 2010
Last Updated: November 17, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Eli Lilly and Company:
Advanced Cancer
Metastatic Cancer
p70s6 inhibitor

ClinicalTrials.gov processed this record on August 28, 2014