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Study Summary
No. 2005-0770:.......Advanced Cancers......David S. Hong......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:		2005-0770
Study Title:A Phase I Dose-Escalation, Pharmacokinetic and Pharmacodynamic Evaluation of Intravenous LY2275796 in Patients with Advanced Cancer
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Physician New Patient Referral
Name:David S. HongPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-5844
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:N/A
Phase of Study:Phase IReturn
Visit:		Patients will return to the clinic each week and approximately 30 days after
the last dose of study drug.
Treatment
Agents:		LY2275796Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		n/a
Description/
Intervention:		The goal of this clinical research study is to find the highest tolerable dose
of a study drug called LY2275796 that can be given to patients with advanced
cancer but not to provide you with treatment for your condition.
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Study Objectives / Outcomes
Primary Objective
To determine a recommended Phase 2 dose of LY2275796 that may be safely administered to patients with advanced cancer, with prospects for therapeutic biologic effects. This will require simultaneous:
  • monitoring of toxicities & determination of maximal tolerated dose (MTD)
  • detecting eIF-4E target inhibition in tumor
  • pharmacokinetic measurements
      Secondary Objectives
          • To estimate pharmacokinetic parameters of LY2275796 and explore pharmacokinetic/pharmacodynamic relationships
          • To document any antitumor activity observed with LY2275796
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      Study Status Information
      Study Activation / Registration Date:09/21/2006
      IRB Review and Approval Date:03/20/2006
      Study Type:Phase I
      Recruitment Status:Terminated
      Projected Accrual:40
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      Enrollment Eligibility
      If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
      Inclusion Criteria:1) Evidence of histologically or cytologically documented malignancy, including patients with treated, stable brain metastases. For Part A: Malignancy that is advanced and/or metastatic for which no proven therapy exists (for example, there is no comparable or satisfactory alternative drug or other therapy available to treat that stage of the disease). For Part B and C: Malignancy that is advanced and/or metastatic for which no proven therapy exists, and presents with disease that is amenable to serial measurement of pharmacodynamics by biopsy.

      2) Male or female >/= 18 years of age

      3) Written informed consent from the patient

      4) Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

      5) Patients must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, or other investigational therapy for at least 4 weeks (2 weeks for palliative radiotherapy, 6 weeks for mitomycin C or nitrosoureas), piror to study enrollment and have recovered from the acute effects of therapy.

      6) Patients are able to comply with the protocol requirements and are reliable and willing to make themselves available for the duration of the study and will abide by the research units policies and procedures.

      7) Have adequate organ function including: Bone Marrow Reserve: Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L prior to treatment, platelets >/= 100 x 10^9/L, hemoglobin >/= 9 g/dL; Hepatic: Bilirubin </= upper limits or normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) </= 2.5 x ULN; Renal: Calculated creatinine clearance by Cockcroft-Gault formula >/= 50 ml/min; Coagulation: Activated prothrombin time (APTT) and prothrombin time (PT) less than or equal to the ULN.

      8) Males and females with reproductive potential should use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
      Exclusion Criteria:1) Patient with current hematological malignancies or bleeding diathesis

      2) Serious pre-existing medical conditions at the discretion of the investigator

      3) Major surgery within 4 weeks of study enrollment

      4) Women who are pregnant or lactating

      5) Symptomatic central nervous system (CNS) neoplasm. (Patients who have CNS neoplasms stable on steroid medication may be included.)

      6) Concomitant anticancer therapy or anticoagulant therapy (with the exception of the use of heparinized saline to maintain the patency of central venous catheters).

      7) Patients who require palliative radiotherapy at the time of study entry

      8) Previous treatment with antisense therapies

      9) Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication

      10) Presence of positive test results in HIV antibodies, Hepatitis B surface antigen, or Hepatitis C antibodies (Rationale: Correlative biologic studies entail aerosolization of biologic fluids. Researchers use Universal precautions and should be protected from HIV or Hepatitis viruses. However, robotic equipment handling specimens with high viral load would require purging and sterilization procedures that could damage the equipment or alter results for subsequent specimens. Patients lacking symptoms or signs of HIV or hepatitis have low viral loads so that screening for them is not necessary).
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      Links
      Registration Number: NCT00903708
      Study Information on Clinical Trials Registry (clinicaltrials.gov)
      Other Links:
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      Results

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