LY2275796 in Advanced Cancer

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. Identifier: NCT00903708
Recruitment Status : Completed
First Posted : May 18, 2009
Last Update Posted : July 30, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: LY2275796 Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation, Pharmacokinetic and Pharmacodynamic Evaluation of Intravenous LY2275796 in Patients With Advanced Cancer
Study Start Date : September 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: LY2275796 Drug: LY2275796
100 mg administered by vein as a loading dose daily over 3 days, and then as a maintenance dose weekly thereafter.

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of LY2275796 [ Time Frame: Dose toxicity with each loading dose (daily for 3 days) then weekly ]
    Maximum tolerated dose (MTD) defined as highest dose at which 0-1/6 patients experience Grade III toxicity with LY2275796 administered IV as a loading dose daily over 3 days, then as maintenance dose weekly.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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), prior 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).

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 identifier (NCT number): NCT00903708

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: David Hong, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00903708     History of Changes
Other Study ID Numbers: 2005-0770
First Posted: May 18, 2009    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Eukaryotic initiation factor 4E

Additional relevant MeSH terms: