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A Study of LY2584702 in Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01241461
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : July 16, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Drug: LY2584702 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY2584702 in Japanese Patients With Solid Tumors
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2584702 Drug: LY2584702

Dose escalation starting at 50 milligram (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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Clinically Significant Effects [ Time Frame: Baseline through 30 days ]
    A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count <50.0 x 10^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count <0.5 x 10^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.


Secondary Outcome Measures :
  1. Number of Participants With Tumor Response [ Time Frame: Baseline to study completion up to Day 183 ]
    Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions.

  2. Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702 [ Time Frame: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose ]
    AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state.

  3. Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702 [ Time Frame: Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 10^9/liter (L), platelets greater than or equal to 100 x 10^9/L, and hemoglobin greater than or equal to 9 gram/deciliter (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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241461


Locations
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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
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01241461    
Other Study ID Numbers: 13871
I3G-JE-JGCC ( Other Identifier: Eli Lilly and Company )
First Posted: November 16, 2010    Key Record Dates
Results First Posted: July 16, 2018
Last Update Posted: August 21, 2018
Last Verified: July 2018
Keywords provided by Eli Lilly and Company:
Advanced Cancer
Metastatic Cancer
p70s6 inhibitor