LY2275796 in Advanced Cancer

NCT00903708 | Completed Phase 1

• 1 other identifier: 2005-0770
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Cancers

Keywords

Advanced Cancers; LY2275796; Eukaryotic initiation factor 4E; eIF-4E

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of LY2275796

  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.

  Dose toxicity with each loading dose (daily for 3 days) then weekly

Study Arms (1)

LY2275796

EXPERIMENTAL

Drug: LY2275796

Interventions

LY2275796 DRUG

100 mg administered by vein as a loading dose daily over 3 days, and then as a maintenance dose weekly thereafter.

LY2275796

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female \>/= 18 years of age
• Written informed consent from the patient
• Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Patient with current hematological malignancies or bleeding diathesis
• Serious pre-existing medical conditions at the discretion of the investigator
• Major surgery within 4 weeks of study enrollment
• Women who are pregnant or lactating
• Symptomatic central nervous system (CNS) neoplasm. (Patients who have CNS neoplasms stable on steroid medication may be included.)
• Concomitant anticancer therapy or anticoagulant therapy (with the exception of the use of heparinized saline to maintain the patency of central venous catheters).
• Patients who require palliative radiotherapy at the time of study entry
• Previous treatment with antisense therapies
• 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
• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Interventions

LY 2275796

Study Officials

• David Hong, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 18, 2009
• Study Start: September 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)